Refine your search

Search Results within category "Senior Health "

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

Search all categories
15 Study Matches

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Claus Roehrborn
16184
Male
45 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03123250
STU 082017-008
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Male age 45-80 years.
• Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
• Subject has an IPSS score greater than or equal to 12.
• Maximum urinary flow rate (Qmax) less than 15mL/s.
• Serum creatinine < 2 mg/dL within 30 days of surgery.
• History of inadequate or failed response, contraindication, or refusal to medical therapy.
• Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
• Patient is mentally capable and willing to sign a study-specific informed consent form.
Exclusion Criteria:

• BMI ≥ 42.
• Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
• Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
• Contraindication to both general and spinal anesthesia.
• Any severe illness that would prevent complete study participation or confound study results.
• History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
• History of actively treated bladder cancer within the past two (2) years.
• Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20% of full bladder size).
• Active infection, including urinary tract infection or prostatitis.
• Urinary catheter use daily for 90 or more days consecutively.
• Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
• Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
• Known damage to external urinary sphincter.
• Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
• Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
• Subject is unwilling to accept a transfusion should one be required.
Device: Aquablation
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS), AQUABEAM, Aquablation, Benign Prostatic Hyperplasia (BPH)
  Email this study information to me
  Contact the study team
  See more information

Reducing Disparities in the Quality of Advance Care Planning for Older Adults (EQUALACP)

Call 214-648-5005
studyfinder@utsouthwestern.edu
Ramona Rhodes
111049
All
65 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03516994
STU 052018-047
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria for Patients:
• African-American or White
• age 65 or greater
• English-speaking
• residing in non-institutional setting
• cognitively able to participate in advance care planning
• Serious or chronic illness including: metastatic cancer; end stage renal disease; advanced liver disease, heart disease or lung disease; amyotrophic lateral sclerosis, severe Parkinson's disease; 2 or more unplanned hospitalizations in the last year; requiring assistance with any basic activity of daily living
• Serious illness based on the following: Clinician answers "no" to the surprise question: "Would you be surprised if this person died in the next 12 months?" Exclusion Criteria for Patients:
• residence in nursing home or assisted living facility
• diagnosis of dementia or unable to consent
• documented advance care plan (living will, health care proxy, MOST form, provider note)
• current or prior use of hospice
• current or prior use of non-hospice palliative care except inpatient palliative care consultation
Behavioral: Respecting Choices First Steps, Behavioral: Five Wishes Form
Congestive Heart Failure, End Stage Renal Disease, Metastatic Cancer, Diabetes Complications, Parkinson Disease, Interstitial Lung Disease, Amyotrophic Lateral Sclerosis, Chronic Obstructive Pulmonary Disease, End Stage Liver Disease
Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans
  Email this study information to me
  Contact the study team
  See more information

Flortaucipir PET Imaging in Subjects With FTD

This study is designed to assess the usefulness of 18F-AV-1451 in Positron Emission Tomography imaging for subjects diagnosed with Frontotemporal Dementia.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Diana Kerwin
146751
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03040713
STU 112016-013
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
• Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
• Can tolerate PET scan procedures
Exclusion Criteria:

• Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
• Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
• Have history of drug or alcohol dependence within the last year
• Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
• Have history of relevant severe drug allergy or hypersensitivity
• Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
• Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
• Possess PET scan evidence of amyloid deposition
• Determined by the investigator to be unsuitable for this type of study
Drug: 18F-AV-1451, Drug: 18F-AV-45
Frontotemporal Dementia
  Email this study information to me
  Contact the study team
  See more information

Treatment of Psychosis and Agitation in Alzheimer's Disease

Clinically, many patients with AD show no response or minimal response to antipsychotics for symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these medications. Antipsychotics have a wide range of side effects, including the risk of increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that led to an FDA black box warning for patients with dementia; a more recent review and meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only partial response to antipsychotics and symptoms persist. For these reasons, the investigators need to study alternative treatment strategies. Currently, there is no FDA-approved medication for the treatment of psychosis or agitation in AD. The investigators innovative project will examine the efficacy and side effects of low dose lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial). The results will determine the potential for a large-scale clinical trial (Phase III) to establish the utility of lithium in these patients.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mustafa Husain
13437
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT02129348
STU 112016-007
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Male and female adults. 2. Diagnosis of possible or probable AD by standard NIA criteria (McKahnn et al, 1984; McKhann et all, 2011) 3. Folstein MMSE 5-26 out of 30 4. Neuropsychiatric Inventory (NPI) agitation/aggression subscale score > 4. On each subscale (frequency X severity), a score higher than 4 represents moderate to severe symptoms. 5. Female patients need to be post-menopausal 6. Availability of informant; patients without an informant will not be recruited. Patients who lack capacity must have a surrogate.
Exclusion Criteria:
1. Medical contraindication to lithium treatment or prior history of intolerability to lithium treatment. Contraindications to lithium in this study include: resting tremor causing functional impairment, history of falls in the last month, untreated thyroid disease or any abnormal thyroid function test (T3, T4, or TSH), creatinine level greater than 1.5 mg/100ml or a glomerular filtration rate less than 44ml/min/ 1.73m2; blood pressure > 150/90 mm Hg; heart rate < 50 bpm; unstable cardiac disease based on history, physical examination, and ECG. 2. Medications, in combination with lithium, known to have adverse renal effects, including therapeutic or higher doses of diuretics, i.e. hydrochlorothiazide greater than 25mg daily or furosemide greater than 10mg daily. Whenever feasible, patients receiving concomitant antidepressants or antipsychotics will be washed off these medications for at least 24 hours before starting lithium. Patients who do not wish to discontinue antipsychotics or antidepressants, typically because of family member/caregiver objection, will be allowed to enter the trial provided there is no contraindication to concomitant lithium use with that specific psychotropic medication. During the trial, patients will be permitted to receive lorazepam as needed up to 1 mg/day for anxiety/insomnia, and non-benzodiazepine hypnotics, e.g., zolpidem. 3. Current clinical diagnosis of schizophrenia, schizoaffective disorder, other psychosis, or bipolar 1 disorder (DSM-IV TR criteria). 4. Current or recent (past 6 months) alcohol or substance dependence (DSM-IV TR criteria). 5. Current major depression or suicidality as assessed by the study psychiatrist. 6. Suicidal behavior or dangerous behavior with serious safety risk or risk of physical harm to self or others. 7. Parkinson's disease, Lewy body disease, multiple sclerosis, CNS infection, Huntington's disease, amyotrophic lateral sclerosis, other major neurological disorder. 8. Clinical stroke with residual neurological deficits. MRI findings of cerebrovascular disease (smallinfarcts, lacunes, periventricular disease) in the absence of clinical stroke with residual neurological deficits will not lead to exclusion. 9. Acute, severe, unstable medical illness. For cancer, patients with active illness or metastases will be excluded, but past history of successfully treated cancer will not lead to exclusion. 10. QTc interval > 460 ms at the time of baseline EKG is an exclusion criterion for treatment. 11. Hypernatremia as determined by serum sodium level > 150 meq/L.
Drug: Lithium, Drug: Placebo
Alzheimer's Disease, Psychosis, Agitation
Alzheimer's disease, psychosis, agitation, aggression, Lithium, delusions, hallucinations
  Email this study information to me
  Contact the study team
  See more information

Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mustafa Husain
13437
All
50 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02446132
STU 082017-020
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, or 12-AVR-131
• Participants from Study 12-AVR-131 with a diagnosis of probable AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
• Either out-patients or residents of an assisted-living facility or a skilled nursing home
• Participants from Study 12-AVR-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
• Participants from Study 12-AVR-131 with a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
• Participants from Study 12-AVR-131 with a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
• Participants from Study 12-AVR-131 with a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
Exclusion Criteria:

• Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
• Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
• Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline
Drug: AVP-786
Agitation in Patients With Dementia of the Alzheimer's Type
  Email this study information to me
  Contact the study team
  See more information

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) (WATER)

A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness will be measured at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Claus Roehrborn
16184
Male
45 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02505919
STU 092015-009
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
• Age from 45 to 80 years.
• Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/exclusion criteria.)
• Subject has an IPSS score greater than or equal to 12 measured at the baseline visit.
• Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/exclusion criteria.)
• Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery.
• History of inadequate response, contraindication, or refusal to medical therapy.
Exclusion Criteria:

• BMI ≥ 42.
• History of prostate cancer or current/suspected bladder cancer.
• Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
• Subjects with a history of actively treated bladder cancer within the past two (2) years.
• Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
• Active infection, including urinary tract infection.
• Prostatitis treated with antibiotics within 1 year of enrollment.
• Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture.
• Subject has damage to external urinary sphincter .
• Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
• PVR > 300 mL.
• Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure.
• Subject has a history of intermittent self-catheterization.
• Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
• Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d).
• Any severe illness that would prevent complete study participation or confound study results.
• Participants using systematic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg).
• Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
• Contraindication to general or spinal anesthesia.
• Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes.
• 31. Subject is unwilling to accept a transfusion should one be required.
Device: AQUABEAM System, Procedure: Transurethral Resection of the Prostate (TURP)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
  Email this study information to me
  Contact the study team
  See more information

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Amanda Fox
149974
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02791880
STU 112015-015
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for aortic stenosis at the University of Texas Southwestern Medical Center.
Exclusion Criteria:
1. The patient cannot or will not provide informed consent. 2. The patient is aged less than 18 years. 3. The patient's pre-procedural hematocrit is less than 25%. 4. The patient has known hepatitis C and/or human immunodeficiency virus infection 5. In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons.
Procedure: Transcatheter Aortic Valve Replacement
Heart Failure, Myocardial Infarction, Stroke, Acute Kidney Injury, Renal Insufficiency, Chronic, Arrhythmias, Cardiac
acute kidney injury, transcatheter aortic valve replacement, genomics, biomarker
  Email this study information to me
  Contact the study team
  See more information

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].
Call 214-648-5005
studyfinder@utsouthwestern.edu
Kyle Womack
18106
All
50 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02477800
STU 092015-034
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:

• Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
• A Clinical Dementia Rating (CDR)-Global Score of 0.5.
• Objective evidence of cognitive impairment at screening
• An MMSE score between 24 and 30 (inclusive)
• Must have a positive amyloid Positron Emission Tomography (PET) scan
• Must consent to apolipoprotein E (ApoE) genotyping
• If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
• Must have a reliable informant or caregiver Key
Exclusion Criteria:

• Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
• Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
• Clinically significant unstable psychiatric illness in past 6 months
• History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
• Indication of impaired renal or liver function
• Have human immunodeficiency virus (HIV) infection
• Have a significant systematic illness or infection in past 30 days
• Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
• Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
• Alcohol or substance abuse in past 1 year
• Taking blood thinners (except for aspirin at a prophylactic dose or less) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Drug: Aducanumab (BIIB037), Drug: Aducanumab (BIIB037), Drug: Placebo
Alzheimer's Disease
BIIB037, Aducanumab
  Email this study information to me
  Contact the study team
  See more information

Identification of Genomic Predictors of Adverse Events After Cardiac Surgery (CABGGenomics)

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Amanda Fox
149974
All
20 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01258231
STU 072014-075
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Undergoing heart surgery
• Willing to provide consent
Exclusion Criteria:

• Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
Heart Failure, Myocardial Infarction, Atrial Fibrillation, Heart, Dysfunction Postoperative, Cardiac Surgery, Genetic Predisposition to Disease
  Email this study information to me
  Contact the study team
  See more information

VITROS Immunodiagnostic Products NT-proBNP II

Call 214-648-5005
studyfinder@utsouthwestern.edu
Deborah Diercks
152662
All
22 Years and over
This study is NOT accepting healthy volunteers
NCT03548909
STU 122017-045
Show full eligibility criteria
Hide eligibility criteria
Acute HF Population (ED setting):
Inclusion Criteria:

• Subjects must have suspicion of HF and acute symptoms at presentation.
• Subjects must be at least 22 years of age.
• Subjects must be willing and able to provide informed consent.
Exclusion Criteria:

• Acute symptoms clearly not secondary to HF.
• Subjects with renal disease on dialysis.
• Subjects unable to comply with the study requirements. Population with suspicion of HF (Outpatient Setting):
Inclusion Criteria:

• Subjects must be at least 22 years of age.
• Subjects must be willing and able to provide informed consent.
• Subjects who present to outpatient centers with suspicion HF.
Exclusion Criteria:

• Symptoms clearly not secondary to HF.
• Subjects with renal disease on dialysis.
• Subjects unable to comply with the study requirements.
• Subjects previously diagnosed with heart failure.
Diagnostic Test: VITROS Immunodiagnostic Products
Heart Failure
NT-proBNP
  Email this study information to me
  Contact the study team
  See more information

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction
Call 214-648-5005
studyfinder@utsouthwestern.edu
Vlad Zaha
163027
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03057951
STU 052017-091
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria:
• Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 years at screening
• Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
• Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
• Stable dose of oral diuretics, if prescribed
• Signed and dated written ICF (informed consent form)
• Further inclusion criteria apply Exclusion criteria:
• Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
• Heart transplant recipient or listed for heart transplant
• Acute decompensated HF (Heart Failure)
• Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
• Symptomatic hypotension and/or a SBP < 100 mmHg
• Indication of liver disease,
• Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
• History of ketoacidosis
• Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
• Currently enrolled in another investigational device or drug trial
• Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Further exclusion criteria may apply
Drug: Empagliflozin, Drug: Placebo
Heart Failure
  Email this study information to me
  Contact the study team
  See more information

Phenotype, Genotype & Biomarkers in ALS and Related Disorders

Call 214-648-5005
studyfinder@utsouthwestern.edu
Jaya Trivedi
46764
All
Not specified
This study is also accepting healthy volunteers
NCT02327845
STU 042016-082
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Member of at least one of the following categories: 1. Individuals with a clinical diagnosis of ALS or a related disorder, including FTD, HSP, PLS, PMA and MSP (sporadic or familial). 2. Family member of an enrolled affected individual.
• Able and willing to comply with relevant procedures.
Exclusion Criteria:

• Affected with end or late stage disease.
• A condition or situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol. This includes (but is not limited to) neurological, psychological and/or medical conditions.
Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Primary Lateral Sclerosis, Hereditary Spastic Paraplegia, Progressive Muscular Atrophy, Multisystem Proteinopathy
natural history, biomarkers, phenotype, genotype
  Email this study information to me
  Contact the study team
  See more information

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Vlad Zaha
163027
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03057977
STU 052017-092
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria:
• Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
• Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
• If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
• If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
• If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
• EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
• Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
• Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
• Signed and dated written ICF (Informed Consent Form)
• Further inclusion criteria apply Exclusion criteria:
• Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
• Heart transplant recipient, or listed for heart transplant
• Acute decompensated HF
• Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
• Symptomatic hypotension and/or a SBP < 100 mmHg
• Indication of liver disease
• Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease
•Epidemiology Collaboration Equation)) or requiring dialysis
• History of ketoacidosis
• Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
• Currently enrolled in another investigational device or drug study
• Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Further exclusion criteria apply
Drug: Empagliflozin, Drug: Placebo
Heart Failure
  Email this study information to me
  Contact the study team
  See more information

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mustafa Husain
13437
All
50 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02442778
STU 042016-037
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
• The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
• The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
• Either out patients or residents of an assisted-living facility or a skilled nursing home
• Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
• Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
• Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.
Exclusion Criteria:

• Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
• Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
• Participant with myasthenia gravis
Drug: AVP-786, Drug: Placebo
Agitation in Patients With Dementia of the Alzheimer's Type
  Email this study information to me
  Contact the study team
  See more information

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol (ADNI3)

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Kyle Womack
18106
All
55 Years to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT02854033
STU 112016-068
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria (all CN participants): 1. Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age 2. Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. 9 for 16 or more years of education 2. 5 for 8-15 years of education 3. 3 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0. Memory Box score must be 0 5. Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Estrogen replacement therapy is permissible 3. Gingko biloba is permissible, but discouraged 4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all MCI participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): a. < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the Screening Visit 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all AD participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. ≤ 8 for 16 or more years of education 2. ≤ 4 for 8-15 years of education 3. ≤ 2 for 0-7 years of education 3. Mini-Mental State Exam score between 20 and 24 inclusive (Exceptions for scores of 24 and 25 may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5 or 1.0 5. NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria Specific to Newly Enrolled Participants 1. Geriatric Depression Scale score less than 6. 2. Age between 55-90 years (inclusive). 3. Study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol. 4. Visual and auditory acuity adequate for neuropsychological testing. 5. Good general health with no diseases expected to interfere with the study. 6. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). 7. Willing and able to participate in a longitudinal imaging study. 8. Modified Hachinski Ischemic Score less than or equal to 4. 9. Completed six grades of education or has a good work history (sufficient to exclude mental retardation). 10. Must speak English or Spanish fluently. 11. Willing to undergo repeated MRIs (3Tesla) and at least two PET scans 12. Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking. 13. Agrees to collection of blood for biomarker testing. 14. Agrees to at least one lumbar puncture for the collection of CSF. 15. Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants" The following additional inclusion criteria apply to all diagnostic categories for rollover participants only: 1. Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year. 2. Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery. Exclusion Criteria (all CN participants): 1. Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities Exclusion Criteria (all MCI participants): 1. Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all AD participants): 1. Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all participants): The following additional exclusion criteria apply to all diagnostic categories: 1. Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure 2. Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body. 3. Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. 4. Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder. 5. History of schizophrenia (DSM IV criteria). 6. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). 7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol. 8. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. 9. Residence in a skilled nursing facility. 10. Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture). 11. Current use of any other exclusionary medications 12. Investigational agents are prohibited one month prior to entry and for the duration of the trial. 13. Participation in clinical studies involving neuropsychological measures being collected more than one time per year. Exclusion Criteria Specific to AV-1451 PET: The following criteria are exclusionary only for the AV-1451 scanning portion of the study: 1. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided. 2. Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, Alzheimer's disease, tau
  Email this study information to me
  Contact the study team
  See more information