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Alzheimer Prevention Trials (APT) Webstudy

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT03638583
Collaborator
National Institute on Aging (NIA) (NIH), Brigham and Women's Hospital (Other), The Cleveland Clinic (Other)
200,000
Enrollment
1
Location
52.3
Anticipated Duration (Months)
3823.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the Alzheimer Prevention Trials (APT) Webstudy is to accelerate enrollment for Alzheimer's disease (AD) clinical trials by identifying and tracking individuals who may be at higher risk for developing AD dementia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The APT Webstudy will use web-based cognitive testing and questionnaires to generate a risk score which will be used to identify individuals who may be at an increased risk for developing AD dementia.

    Individuals who join the APT Webstudy will register at https://www.aptwebstudy.org/, sign an electronic informed consent form (ICF), provide basic demographic information and participate in web-based cognitive testing. Participants will return the APT Webstudy quarterly (every 3 months) to complete the cognitive testing again.

    Based on the risk score and changes identified in the cognitive testing results, participants will be invited to visit a partnering clinical trial site for an in-person visit with biomarker testing and clinical assessment.

    The combined results of the web-based assessments, with the biomarker and clinical assessments, will allow an adaptive statistical algorithm to improve the selection of those at highest risk for developing AD.

    To Join the APT Webstudy, please visit https://www.aptwebstudy.org/.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200000 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Alzheimer Prevention Trials (APT) Webstudy
    Actual Study Start Date :
    Dec 20, 2017
    Anticipated Primary Completion Date :
    Apr 30, 2022
    Anticipated Study Completion Date :
    Apr 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Enrollment into Alzheimer's prevention research studies [5 years]

    Secondary Outcome Measures

    1. Referral into prevention research studies [5 years]

    2. Number of individuals enrolled into Alzheimer's prevention studies [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • male or female at least 50 years of age

    • no evidence of dementia

    • willing to participate in remote longitudinal cognitive testing and possible referral for biomarker assessment based on risk

    Exclusion Criteria:
    • N/A. Anyone can register for the APT Webstudy, however, only individuals identified using the risk algorithm will be referred for in-person biomarker assessments.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Https://Www.Aptwebstudy.Org San Diego California United States 92121

    Sponsors and Collaborators

    • University of Southern California
    • National Institute on Aging (NIA)
    • Brigham and Women's Hospital
    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Paul Aisen, MD, USC ATRI
    • Principal Investigator: Reisa Sperling, MD, Brigham and Women's Hospital
    • Principal Investigator: Jeffrey Cummings, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul Aisen, Professor, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03638583
    Other Study ID Numbers:
    • HS-17-00746
    • R01AG053798
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Paul Aisen, Professor, University of Southern California
    Alzheimer's
    Prevention
    Web-Based
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Feb 25, 2022