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.
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE)
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study
conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia
will demonstrate the benefit of statins for reducing the primary composite of death,
dementia, and persistent disability and secondary composites including mild cognitive
impairment (MCI) and cardiovascular events.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Rubin
16278
All
75 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT04262206
STU-2020-0579
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Inclusion Criteria:
• Community-dwelling adults
• Age 75 years or older
Exclusion Criteria:
• Clinically evident CVD, defined as prior MI, prior stroke, prior revascularization
procedure, or a secondary prevention indication for a statin as determined by their
clinician.
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note:
History of heart failure without clinically evident cardiovascular disease is not an
exclusion)
• Dementia (clinically evident and/or previously diagnosed)
• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of
urinary or bowel continence)
• Severe hearing impairment (preventing phone follow up)
• Severe visual impairment (preventing cognitive testing)
• Statin use in the past year or for longer than 5 years previously (participant
reported)
• Ineligible to take atorvastatin 40 mg (clinician determined)
• Documented intolerance to statins
• Active liver disease
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
The primary objective is to evaluate the long-term safety and tolerability of aducanumab
after a wash-out period imposed by discontinuation of feeder studies in participants who had
previously received aducanumab (i.e. previously treated participants) or who had previously
received placebo (i.e. treatment-naïve participants).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Trung Nguyen
157574
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT04241068
STU-2020-0282
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Inclusion Criteria:
• Participant was participating in an aducanumab clinical study at the time of the
announcement of early termination (feeder studies).
• Has one care partner who, in the Investigator's opinion, has adequate contact with the
participant as to be able to provide accurate information about the participant's
cognitive and functional abilities.
Exclusion Criteria:
• Any medical or neurological condition (other than Alzheimer's Disease) that might be a
contributing cause of the subject's cognitive impairment.
• Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
• 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.
• A seizure event that occurred after the last visit of the feeder study and before
Screening for this study.
• Evidence of impaired liver function as shown by an abnormal liver function profile at
Screening.
• History of or known seropositivity for HIV.
• Clinically significant systemic illness or serious infection within 30 days prior to
or during Screening.
• Contraindications to having a brain magnetic resonance imaging (MRI).
Note- Other protocol defined Inclusion/Exclusion criteria may apply.
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
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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.
The Effects of Low Dose Ketamine on Cardiovascular Function
Low dose ketamine is used for pain management and for the treatment of anxiety and
depression. Prior studies on low dose ketamine have noted short-term (minutes to hours)
increases or decreases in blood pressure. Blood pressure that is too high or too low can be
problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure.
In fact, no prior studies have measured sympathetic nervous system activity after low dose
ketamine has been given to an adult. Because sympathetic nervous system activity has a large
influence on blood pressure, we need to know how exactly low dose ketamine affects these body
systems. Therefore, in this research we will study how low dose ketamine affects sympathetic
nervous system activity and cardiovascular function. The results from this research will
inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and
blood vessels.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04429685
STU-2019-1792
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Inclusion Criteria:
• Non-obese (body mass index less than 30 kg/m2)
*alternatively, individuals will be permitted to participate if they have a body mass
index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102
cm for males
• Systolic blood pressure <140 mmHg
• Diastolic blood pressure <90 mmHg
Exclusion Criteria:
• Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
• Current or previous use of anti-hypertensive medications
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Individuals with a history of drug abuse
• Individuals who have an unexplained positive urine drug screen (e.g., some agents
cause false-positive results, but when the agent is abstained for hours/days/weeks,
the repeated drug screen is negative. One example could be an over-the-counter
supplement)
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
We are examining how morphine (a commonly used pain medication) will alter responses to
simulated blood loss in humans. To simulate blood loss in our research laboratory,
participants will complete a test with their lower body in a custom-designed vacuum chamber
for a brief period of time.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04138615
STU 092017-070
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Inclusion Criteria:
• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
Exclusion Criteria:
• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)
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
Brendan Kelley
173025
All
55 Years to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT02854033
STU 112016-068
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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), Brain and Nervous System
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, Alzheimer's disease, tau
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic (PREEMPT-HF)
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate
extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad
spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac
resynchronization therapy defibrillator. There are no primary safety and/or efficacy
endpoints for this study.
Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic
burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by
episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet
clinical need to slow the progression of Heart Failure and prevent hospitalizations.
HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and
defibrillators, combines novel sensor parameters such as heart sounds and respiration with
other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index
for the early detection of worsening Heart Failure. However, there is limited data on the
association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or
for phenotyping the broad spectrum of Heart Failure patients.
Call 214-648-5005 studyfinder@utsouthwestern.edu
James Daniels
46951
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03579641
STU 072018-065
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Inclusion Criteria:
• Subject is age 18 or above, or of legal age to give informed consent specific to each
country and national laws.
• Subject has a documented diagnosis of heart failure.
• Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or
Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart
Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor
turned ON.
• Subject has an active bipolar right ventricle lead implant.
• Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be
remotely monitored from the baseline visit for approximately 12 months with HeartLogic
disabled.
Exclusion Criteria:
• Subject has received or is scheduled to receive a heart transplant or ventricular
assist device (VAD).
• Subject is enrolled in any concurrent clinical study without prior Boston Scientific
written approval (excluding registries).
• Subject has a life expectancy of less than 12 months.
• Subject has a history of non-compliance to medical care or known inability to comply
with requirements of the clinical study protocol