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Alzheimer Prevention Trials (APT) Webstudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638583
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : October 21, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Brigham and Women's Hospital
The Cleveland Clinic
Information provided by (Responsible Party):
Paul Aisen, University of Southern California

Tracking Information
First Submitted Date August 16, 2018
First Posted Date August 20, 2018
Last Update Posted Date October 21, 2022
Actual Study Start Date December 20, 2017
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2018)
Enrollment into Alzheimer's prevention research studies [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 16, 2018)
  • Referral into prevention research studies [ Time Frame: 5 years ]
  • Number of individuals enrolled into Alzheimer's prevention studies [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alzheimer Prevention Trials (APT) Webstudy
Official Title Alzheimer Prevention Trials (APT) Webstudy
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Anyone who meets entry criteria is eligible to join the Webstudy. We anticipate 200,000 individuals will join.
Condition
  • Alzheimer Disease
  • Dementia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2018)
200000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: APT Webstudy Team 858-877-3135 info@aptwebstudy.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03638583
Other Study ID Numbers HS-17-00746
R01AG053798 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Paul Aisen, University of Southern California
Original Responsible Party Same as current
Current Study Sponsor University of Southern California
Original Study Sponsor Same as current
Collaborators
  • 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
PRS Account University of Southern California
Verification Date October 2022