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Preclinical Alzheimer's DiseaseTRC-PADNCT04004767

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

An observational study of Preclinical Alzheimer's Disease and Prodromal Alzheimer's Disease, run by University of Southern California at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
How many people
220 participants
Where
45 sitesUnited States
Study dates
4 Jun 2019to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: AD biomarker confirmed individuals who may be at an increased risk for memory loss caused by Alzheimer's disease dementia. Individuals at highest risk within the APT Webstudy will be referred for an in-person TRC-PAD visit. Individuals with known biomarker status may qualify for a direct referral to the trial-ready cohort.

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated availability and willingness to comply with all study procedures until referred to a clinical trial
  • Age 50-85 (inclusive)
  • Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia
  • Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function.
  • In good general health as evidenced by medical history
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  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Fluent in English or Spanish
  • For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan
  • Completed six grades of education or has a good work history
  • Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center.

Who cannot join

  • Treatment with an another anti-amyloid investigational anti-amyloid drug or other experimental intervention within 12 months. Use of aducanumab or other approved anti-amyloid treatments allowed if stable for at least 3 months.
  • Enrolled in another interventional clinical trial within the last 12 weeks
  • Any significant neurologic 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 followed by persistent neurologic deficits or known structural brain abnormalities.
  • Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
  • History of schizophrenia (DSM V criteria)
  • History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
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  • Clinically significant or unstable medical condition, including uncontrolled hypertension, 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, or influence the results, or the participant's ability to participate in the study.
  • History within the last 3 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 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.
  • Clinically significant abnormalities in screening laboratories or ECG.
  • For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin)
  • Participants whom the Site PI deems to be otherwise ineligible.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Case Western Reserve University

    Beachwood, Ohio, 44195

  • University of Alabama

    Birmingham, Alabama, 35294

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Roper St. Francis Hospital

    Charleston, South Carolina, 29401

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • University of Kansas

    Fairway, Kansas, 66205

  • University of North Texas Health Sciences Center

    Fort Worth, Texas, 76107

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California, Irvine

    Irvine, California, 92697

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • University of Kentucky

    Lexington, Kentucky, 40504

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33125

  • Wien Center for Alzheimer's Disease

    Miami Beach, Florida, 33140

  • Yale University

    New Haven, Connecticut, 06510

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Synexus Clinical Research Orlando

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts, 02360

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

  • National Clinical Research, Inc.

    Richmond, Virginia, 23294

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

  • University of Rochester Medical Center

    Rochester, New York, 14620

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

    Seattle, Washington, 98108

  • Washington University, St. Louis

    St Louis, Missouri, 63130

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 33613

  • Synexus Clinical Research, The Villages

    The Villages, Florida, 32162-7116

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Charter Research, LLC

    Winter Park, Florida, 32792

Other trials in United States

About this study

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

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).

Read the detailed 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.

Keywords
Alzheimer's, Prevention, Observational, Trial-Ready Cohort
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04004767
Study groupRoleWhat they receive
TRC-PAD CohortIndividuals identified as being at an increased risk for memory loss caused by Alzheimer's disease dementia. Determination of risk based on a number of factors including family history, performance on memory tests, genetic tests and biomarker tests.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment into preclinical and prodromal AD clinical trials

    Measured: 5 years

Secondary outcomes (1)

  1. Optimization of adaptive risk algorithm to predict risk of amyloid positivity

    The TRC-PAD program aims to optimize an innovative, adaptive risk algorithm to efficiently identify the most appropriate trial participants. Once optimized, this algorithm will be able to select amyloid positive individuals (and eventually tau and other neurodegenerative biomarkers) with >75% accuracy, greatly reducing future costly biomarker screen fails.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start4 Jun 2019
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004767
Sponsor's protocol ID
ATRI-004
Other IDs
R01AG053798
Acronym
TRC-PAD
Status last verified
Jun 2024
First submitted
28 Jun 2019
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375.

    PubMed 25706191

  • Mormino EC, Papp KV, Rentz DM, Donohue MC, Amariglio R, Quiroz YT, Chhatwal J, Marshall GA, Donovan N, Jackson J, Gatchel JR, Hanseeuw BJ, Schultz AP, Aisen PS, Johnson KA, Sperling RA. Early and late change on the preclinical Alzheimer's cognitive composite in clinically normal older individuals with elevated amyloid beta. Alzheimers Dement. 2017 Sep;13(9):1004-1012. doi: 10.1016/j.jalz.2017.01.018. Epub 2017 Feb 28.

    PubMed 28253478

Questions about this trial

What is this clinical trial studying?

An observational study of Preclinical Alzheimer's Disease and Prodromal Alzheimer's Disease, run by University of Southern California at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment into preclinical and prodromal AD clinical trials (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004767, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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