TRC-PAD Program: In-Clinic Trial-Ready Cohort

Last updated: June 25, 2024
Sponsor: University of Southern California
Overall Status: Completed

Phase

N/A

Condition

Dementia

Treatment

N/A

Clinical Study ID

NCT04004767
ATRI-004
R01AG053798
  • Ages 50-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort.

If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated availability and willingness to comply with all study procedures untilreferred to a clinical trial

  3. Age 50-85 (inclusive)

  4. Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia

  5. Has a study partner that is willing to participate as a source of information andhas at least weekly contact with the participant (contact can be in-person, viatelephone or electronic communication). The study partner must have sufficientcontact such that the investigator feels the study partner can provide meaningfulinformation about the participant's daily function.

  6. In good general health as evidenced by medical history

  7. Adequate visual and auditory acuity to allow neuropsychological testing

  8. Fluent in English or Spanish

  9. For females who are not surgically sterile or post-menopausal by two years,receiving a Positron Emission Tomography (PET) scan for amyloid biomarkerconfirmation: negative pregnancy test prior to amyloid PET scan

  10. Completed six grades of education or has a good work history

  11. Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessedby central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloidtesting results may be used with approval from the Coordinating Center.

Exclusion

Exclusion Criteria:

  1. Treatment with an another anti-amyloid investigational anti-amyloid drug or otherexperimental intervention within 12 months. Use of aducanumab or other approvedanti-amyloid treatments allowed if stable for at least 3 months.

  2. Enrolled in another interventional clinical trial within the last 12 weeks

  3. Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson'sdisease, multi-infarct dementia, Huntington's disease, normal pressurehydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,subdural hematoma, multiple sclerosis, or history of significant head traumafollowed by persistent neurologic deficits or known structural brain abnormalities.

  4. Major depression, bipolar disorder as described in DSM-V within the past 1 year orpsychotic features, agitation or behavioral problems within 3 months, which couldlead to difficulty complying with the protocol

  5. History of schizophrenia (DSM V criteria)

  6. History of alcohol or substance abuse or dependence within the past 2 years (DSM Vcriteria)

  7. Clinically significant or unstable medical condition, including uncontrolledhypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal,hepatic, endocrine, or other systemic disease in the opinion of the Investigator,may either put the participant at risk because of participation in the study, orinfluence the results, or the participant's ability to participate in the study.

  8. History within the last 3 years of a primary or recurrent malignant disease with theexception of non-melanoma skin cancers, resected cutaneous squamous cell carcinomain situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostatecancer with normal prostate-specific antigen post-treatment

  9. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) thatmight interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is notphysiologically significant.

  10. Clinically significant abnormalities in screening laboratories or ECG.

  11. For participants undergoing CSF collection: a current blood clotting or bleedingdisorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin)

  12. Participants whom the Site PI deems to be otherwise ineligible.

Study Design

Total Participants: 220
Study Start date:
June 04, 2019
Estimated Completion Date:
April 01, 2024

Study Description

TRC-PAD study is short for the "Trial-Ready Cohort for the Prevention of Alzheimer's Dementia". The purpose of the TRC-PAD study is to find many people (also called a "cohort") who are interested in participating 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 allow new treatments to be discovered as soon as possible.

The TRC-PAD study is for individuals, age 50 and older, who may be at increased risk for memory loss caused by Alzheimer's disease. To join the TRC-PAD study, you first need to be invited to complete an in-person TRC-PAD visit.

How can I be invited to an in-person visit for TRC-PAD? Members of the Alzheimer Prevention Trials (APT) Webstudy complete online questionnaires and memory tests. The results of these tests will identify individuals as being eligible for an in-person TRC-PAD visit. If you are not enrolled in the APT Webstudy, you may be invited to an in-person visit for TRC-PAD because other tests or procedures you have had suggest you might be eligible to participate.

How might the TRC-PAD Study help researchers learn more about Alzheimer's disease dementia? Alzheimer's disease remains one of the most important medical conditions for which there is no treatment. Among the top ten causes of death, Alzheimer's disease is the only one that cannot be prevented, cured, or even slowed. To change this, researchers are conducting clinical trials to find new treatments. These trials need to study large numbers of individuals and follow participants over long periods of time. The goal of TRC-PAD is to identify individuals for these trials. TRC-PAD will find a group of people who may be "at-risk" for developing Alzheimer's dementia in the future and are appropriate for prevention trials.

How does TRC-PAD decide that I may have an increased risk for developing Alzheimer's dementia? A person's risk for developing Alzheimer's dementia is determined by a number of factors including family history, performance on memory tests, and biological tests called biomarkers. Biomarkers are measurements in parts of the body - like blood tests or brain scans - to help assess the presence of, or potential to develop, a disease.

If I decide to join TRC-PAD, what happens? Individuals in the TRC-PAD study will complete several assessments to see if they qualify to join the cohort. This will include biomarker testing (via Positron Emission Tomography (PET) brain scan or spinal fluid collection), tests of memory and thinking, questionnaires about daily functioning, mood and behavior, genetic testing and routine blood and urine tests. Individuals who are determined to eligible to enroll in TRC will come back to the clinic every 6 months for brief longitudinal follow-up visits with questionnaires and testing until that individual qualifies for a clinical trial.

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • University of California, Davis

    Davis, California 95616
    United States

    Site Not Available

  • Sun Valley Research Center, Inc

    Imperial, California 92251
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Hoag Pickup Family Neurosciences Institute

    Newport Beach, California 92663
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California, Davis

    Walnut Creek, California 945985900
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida 33125
    United States

    Site Not Available

  • Wien Center for Alzheimer's Disease

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Synexus Clinical Research Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Brain Matters Research

    Stuart, Florida 34997
    United States

    Site Not Available

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida 33613
    United States

    Site Not Available

  • Synexus Clinical Research, The Villages

    The Villages, Florida 32162-7116
    United States

    Site Not Available

  • Charter Research, LLC

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Columbus Memory Center

    Columbus, Georgia 31909
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas

    Fairway, Kansas 66205
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Washington University, St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14620
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Case Western Reserve University

    Beachwood, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Abington Neurological Associates

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Roper St. Francis Hospital

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of North Texas Health Sciences Center

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • National Clinical Research, Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • University of Washington / Seattle Institute for Biomedical and Clinical Research

    Seattle, Washington 98108
    United States

    Site Not Available

  • University of Wisconsin-Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

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