Trial-Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD)

What Is This Study About?

The Trial-Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD) is an observational study designed to create a group of cognitively healthy volunteers willing to participate in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer's dementia. TRC-PAD will help researchers enroll participants into these trials quickly. To join the TRC-PAD study, individuals must first complete an Alzheimer Prevention Trials (APT) Webstudy online questionnaire and memory tests. If selected, participants will make an in-person visit to a study site, where they will complete several assessments to see if they qualify to join the cohort. These assessments include a positron emission tomography (PET) brain scan, cerebrospinal fluid collection, tests of memory and thinking, questionnaires about daily functioning, mood and behavior, genetic testing, and routine blood and urine tests. Individuals who enroll in TRC-PAD will come back to the clinic every six months for brief follow-up visits, with questionnaires and testing, until they qualify for a clinical trial.

Do I Qualify To Participate in This Study?

Must have:

• Global Clinical Dementia Rating score of 0 or 0.5 and no diagnosis of dementia
• Study partner who is willing to participate as a source of information and has at least weekly contact (in-person, via telephone, or electronic communication) with the participant
• Good general health
• Adequate visual and auditory ability to allow neuropsychological testing
• Fluent in English or Spanish
• Females who are not surgically sterile or postmenopausal for two years must receive a negative pregnancy test prior to amyloid PET scan
• Completed six grades of education or has a good work history
• Evidence of elevated or intermediate levels of brain amyloid, as assessed by amyloid PET or cerebrospinal fluid data; prior amyloid testing results may be used with approval from the Coordinating Center

Must NOT have:

• Treatment with another anti-amyloid drug or other experimental treatment within past 12 months; use of aducanumab or other FDA-approved anti-amyloid treatments allowed, if dosage stable for at least three months
• Enrolled in another interventional clinical trial within the last 12 weeks
• Any significant neurological disease such as Alzheimer's disease dementia, 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
• Major depression, bipolar disorder, agitation or behavioral problems within the past three months that could lead to difficulty complying with the study; history of schizophrenia
• History of alcohol or substance abuse or dependence within the past two years
• Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease
• History within the last three years of a primary or recurrent malignant disease, with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
• Clinically significant abnormalities in vitamin B12 or thyroid function tests
• Clinically significant abnormalities in laboratory tests or electrocardiogram
• For participants undergoing cerebrospinal fluid collection, current blood clotting or bleeding disorder

 

Who Is the General Study Contact?

For more information visit the TRC-PAD website.

Where Is This Study Located?

Alabama
University of Alabama Birmingham, AL 35294 Recruiting
Arizona
Banner Alzheimer's Institute Phoenix, AZ 85006 Recruiting
Banner Sun Health Research Institute Sun City, AZ 85351 Recruiting
California
Sun Valley Research Center, Inc Imperial, CA 92251 Not yet recruiting
University of California, Irvine Irvine, CA 92697 Recruiting
University of Southern California Los Angeles, CA 90033 Recruiting
Connecticut
Yale University New Haven, CT 06510 Recruiting
District of Columbia
Georgetown University Washington, DC 200072145 Recruiting
Florida
Mayo Clinic Jacksonville Jacksonville, FL 32224 Recruiting
Gonzalez MD & Aswad MD Health Services Miami, FL 33125 Recruiting
Wien Center for Alzheimer's Disease Miami Beach, FL 33140 Recruiting
Renstar Medical Research Ocala, FL 34470 Recruiting
Synexus Clinical Research Orlando Orlando, FL 32806 Recruiting
Progressive Medical Research Port Orange, FL 32127 Recruiting
Brain Matters Research Stuart, FL 34997 Recruiting
University of South Florida - Health Byrd Alzheimer Institute Tampa, FL 33613 Recruiting
Synexus Clinical Research, The Villages The Villages, FL 32162 Recruiting
Charter Research, LLC Winter Park, FL 32792 Recruiting
Georgia
Columbus Memory Center Columbus, GA 31909 Recruiting
Illinois
Northwestern University Chicago, IL 60611 Recruiting
Rush University Chicago, IL 60612 Recruiting
Indiana
Indiana University Indianapolis, IN 46202 Recruiting
Kansas
University of Kansas Fairway, KS 66205 Recruiting
Kentucky
University of Kentucky Lexington, KY 40504 Recruiting
Maryland
Johns Hopkins University Baltimore, MD 21224 Recruiting
Massachusetts
Brigham & Women's Hospital Boston, MA 02115 Recruiting
Headlands Eastern MA, LLC Plymouth, MA 02360 Recruiting
Michigan
University of Michigan Ann Arbor, MI 48105 Recruiting
Minnesota
Mayo Clinic Rochester Rochester, MN 55902 Recruiting
Missouri
Washington University, St. Louis Saint Louis, MO 63130 Recruiting
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas, NV 89106 Recruiting
New York
University of Rochester Medical Center Rochester, NY 14620 Recruiting
North Carolina
Wake Forest University Health Sciences Winston-Salem, NC 27157 Recruiting
Ohio
Case Western Reserve University Beachwood, OH 44195 Recruiting
Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland Cleveland, OH 44195 Recruiting
Ohio State University Columbus, OH 43210 Recruiting
Oregon
Oregon Health & Science University Portland, OR 97239 Recruiting
Pennsylvania
Abington Neurological Associates Abington, PA 19001 Recruiting
University of Pennsylvania Philadelphia, PA 19104 Recruiting
Rhode Island
Rhode Island Hospital Providence, RI 02903 Recruiting
Butler Hospital Memory and Aging Program Providence, RI 02908 Recruiting
South Carolina
Ralph H. Johnson VA Medical Center Charleston, SC 29401 Not yet recruiting
Texas
University of Texas Southwestern Medical Center Dallas, TX 75390 Recruiting
University of North Texas Health Sciences Center Fort Worth, TX 76107 Recruiting
Virginia
National Clinical Research, Inc. Richmond, VA 23294 Recruiting
Washington
University of Washington / Seattle Institute for Biomedical and Clinical Research Seattle, WA 98108 Recruiting
Wisconsin
University of Wisconsin-Madison Madison, WI 53792 Recruiting

Who Sponsors This Study?

Lead: University of Southern California

Collaborator Sponsor

• National Institute on Aging (NIA)
• Alzheimer's Therapeutic Research Institute
• Alzheimer's Clinical Trials Consortium
• Brigham and Women's Hospital
• Cleveland Clinic Lou Ruvo Center for Brain Health

Source: ClinicalTrials.gov ID: NCT04004767