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

NCT04004767 | Completed DMC

• 2 other identifiers: ATRI-004R01AG053798
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 45

Brief 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).

Conditions

Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer Disease; Dementia

Keywords

Alzheimer's; Prevention; Observational; Trial-Ready Cohort

Outcome Measures

Primary Outcomes (1)

• Enrollment into preclinical and prodromal AD clinical trials

  5 years

Secondary Outcomes (1)

• Optimization of adaptive risk algorithm to predict risk of amyloid positivity

  5 years

Study Arms (1)

TRC-PAD Cohort

Individuals 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.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)
• 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 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.

Sponsors & Collaborators

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

Study Sites (45)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Gonzalez MD & Aswad MD Health Services

Miami, Florida, 33125, United States

Location

Wien Center for Alzheimer's Disease

Miami Beach, Florida, 33140, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Synexus Clinical Research Orlando

Orlando, Florida, 32806, United States

Location

University of South Florida - Health Byrd Alzheimer Institute

Tampa, Florida, 33613, United States

Location

Synexus Clinical Research, The Villages

The Villages, Florida, 32162-7116, United States

Location

Charter Research, LLC

Winter Park, Florida, 32792, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas

Fairway, Kansas, 66205, United States

Location

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Headlands Eastern MA LLC

Plymouth, Massachusetts, 02360, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63130, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University

Beachwood, Ohio, 44195, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Abington Neurological Associates

Abington, Pennsylvania, 19001, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Butler Hospital Memory and Aging Program

Providence, Rhode Island, 02906, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Roper St. Francis Hospital

Charleston, South Carolina, 29401, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of North Texas Health Sciences Center

Fort Worth, Texas, 76107, United States

Location

National Clinical Research, Inc.

Richmond, Virginia, 23294, United States

Location

University of Washington / Seattle Institute for Biomedical and Clinical Research

Seattle, Washington, 98108, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 25706191 BACKGROUND

• 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.

  PMID: 28253478 BACKGROUND

Related Links

• APT Webstudy
• ATRI Studies
• Alzheimer's Clinical Trials Consortium

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, CSF

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Paul Aisen, MD

  USC Alzheimer's Therapeutic Research Institute (ATRI)

  PRINCIPAL INVESTIGATOR

• Reisa Sperling, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Jeffrey Cummings, MD

  Cleveland Clinic Lou Ruvo Center for Brain Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: June 4, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (45)