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
• English or Spanish as primary language
Exclusion Criteria:
• Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI),
prior stroke, prior revascularization procedure, or a secondary prevention indication
for a statin (clinician determined)
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note:
History of heart failure in the absence of recent hospitalization or clinically
evident cardiovascular disease is not an exclusion)
• Dementia (clinically evident 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)
• Unable to talk (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
• Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose
>240mg/day.
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)
PST for Care Partners of Adults With Alzheimer's and Alzheimer'S-related Dementia
Caregivers of individuals with Alzheimer's disease and related dementia rarely get the
preparation or training they need to manage their caregiving responsibilities and to
successfully balance their own self-care and their caregiving roles. As a result, caregivers
often experience caregiver burden, emotional distress, and substance abuse. Therefore, there
is a critical need to support the emotional and social functioning of caregivers to improve
their health and well-being and to prevent caregiver burden and poor coping.
Problem solving training (PST) is an evidence-based approach that teaches and empowers
individuals to solve emergent problems contributing to their depressive symptoms, helps
improve coping skills and increases self-efficacy. However, critical gaps in knowledge and
care remain regarding the necessary components of training (eg. How many sessions? What is
the influence of personal factors?) that affect how effective PST is for individual
caregivers. Finally, caregiver interventions have almost exclusively been tested in
English-speaking caregivers, further contributing to existing health disparities among
minority groups.
To address this critical need, Dr. Shannon Juengst, Assistant Professor of Physical Medicine
and Rehabilitation was awarded a new Texas Alzheimer's Research and Care Consortium
Collaborative Research Grant entitled, "Problem Solving Training (PST) for English- and
Spanish-speaking Care Partners of Adults with Alzheimer's and Alzheimer's Related Dementia."
For this project, Dr. Juengst has assembled a strong, multidisciplinary team with Dr. Gladys
Maestre, Professor of Biomedical Sciences and Director of the NIA funded-Alzheimer's Disease
Resource Center for Minority and Aging Research and Memory Disorders Center at UT Rio Grande
Valley and Dr. Matthew Smith, Associate Professor of Environmental and Occupational Health
and Co-Director of the Center for Population Health and Aging at Texas A&M University.
This project will establish the necessary guidelines for an evidence-based, implementable
problem-solving intervention for both English- and Spanish-speaking caregivers to improve
their health and well-being and identify potential mechanisms of action for such training.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Shannon Juengst
171396
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04748666
STU-2020-1276
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Inclusion Criteria:
• PHQ2 Score of 2 or higher and/or ZBI4 Score of 2 or higher
• 18 years or older
• Able to speak fluently in English or Spanish
• Cognitively able to make decisions, as determined by ability to provide informed
consent
• Care partner/caregiver to individual with AD/ADRD
• Individual must have at least one year or more of a relationship with patient with
AD/ADRD
Exclusion Criteria:
• Dispute over care partner's role in the care of patient
• Has previously participated in other PST study at UTSW within the past year
• Does not meet all the inclusion criteria
Behavioral: Problem Solving Training
Alzheimer Disease, Mild Cognitive Impairment (MCI), Frontotemporal Degeneration (FTD), Lewy Body Dementia (LBD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Mixed Etiology Dementias (MED)
Alzheimer Disease, Frontotemporal Degeneration, Lewy Body Dementia, Vascular contributions to cognitive impairment and dementia, Mixed etiology dementias, Mild Cognitive Impairment, Care partner, Caregiver, Alzheimer's-related Dementia
UT Southwestern; Parkland Health & Hospital System
Polypill Strategy for Heart Failure With Reduced Ejection Fraction
Heart failure with a reduced ejection fraction (HFrEF) represents a significant public health
burden in the United States, with a growing prevalence particularly among African Americans
and Hispanic Americans and individuals of low socioeconomic status (SES). Although effective
therapies exist, gaps in their uptake contribute substantially to the excess burden of heart
failure. The "polypill" is an inexpensive once daily pill containing three agents proven to
improve morbidity and mortality in heart failure and represents potential strategy for
increasing the utilization of proven HF therapies. The proposed study is a pragmatic,
single-center, randomized trial to test the feasibility and effectiveness of a polypill-based
strategy for the treatment of HFrEF in a low-income, racially diverse population.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04633005
STU-2020-1340
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Inclusion Criteria:
• Adults age > = 18 years
• HF with left ventricular ejection fraction <= 40% within 3 months of screening who are
not on optimal guideline directed medical therapy
• New York Heart Association class II, III, or IV symptoms
Exclusion Criteria:
• Age < 18
• Systolic blood pressure < 120 mm Hg at enrollment
• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified
• MDRD formula
• Serum potassium > 5.0 mEq/L
• Current need for inotropes
• Cardiac index < 2.2 L/min/m2
• History of revascularization within 30 days or plan for revascularization
• History of type 1 diabetes mellitus
• History of allergic reaction or contraindication to a beta-blocker (BB),
mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2
inhibitor (SGLT2i)
• Contraindication to receive any of the components of the polypill
• Pregnancy
• < 12 month expected survival
• Inability to provide written informed consent
• Persistent or permanent atrial fibrillation who may not have optimal MRI imaging
• Extreme obesity (BMI > 45 kg/m2)
• ICD/PAcemaker devices that are incompatible with MRI
Drug: Polypill, Drug: Control Rx
Heart Failure, Heart
UT Southwestern; Parkland Health & Hospital System
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)
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