ClinicalTrials.gov

History of Changes for Study: NCT03638583
Alzheimer Prevention Trials Webstudy
Latest version (submitted October 19, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 16, 2018 None (earliest Version on record)
2 October 10, 2019 Study Status
3 October 28, 2019 Study Identification and Study Status
4 November 2, 2020 Study Status
5 February 24, 2022 Study Status
6 October 19, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03638583
Submitted Date:  August 16, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: HS-17-00746
Brief Title: Alzheimer Prevention Trials Webstudy
Official Title: Alzheimer Prevention Trials Webstudy
Secondary IDs: R01AG053798 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: August 2018
Overall Status: Recruiting
Study Start: December 20, 2017
Primary Completion: April 30, 2022 [Anticipated]
Study Completion: April 30, 2022 [Anticipated]
First Submitted: August 16, 2018
First Submitted that
Met QC Criteria:
August 16, 2018
First Posted: August 20, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 16, 2018
Last Update Posted: August 20, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Southern California
Responsible Party: Principal Investigator
Investigator: Paul Aisen
Official Title: Professor
Affiliation: University of Southern California
Collaborators: National Institute on Aging (NIA)
Brigham and Women's Hospital
The Cleveland Clinic
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
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/.

Open or close this module Conditions
Conditions: Alzheimer Disease
Dementia
Keywords: Alzheimer's
Prevention
Web-Based
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Other
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 200000 [Anticipated]
Number of Groups/Cohorts 0
Target Follow-Up Duration: 5 Years
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Enrollment into Alzheimer's prevention research studies
[ Time Frame: 5 years ]

Secondary Outcome Measures:
1. Referral into prevention research studies
[ Time Frame: 5 years ]

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

Open or close this module Eligibility
Study Population: Anyone who meets entry criteria is eligible to join the Webstudy. We anticipate 200,000 individuals will join.
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Central Contact Person: APT Webstudy Team
Telephone: 858-877-3135
Email: info@aptwebstudy.org
Study Officials: Paul Aisen, MD
Principal Investigator
USC ATRI
Reisa Sperling, MD
Principal Investigator
Brigham and Women's Hospital
Jeffrey Cummings, MD
Principal Investigator
The Cleveland Clinic
Locations: United States, California
Https://Www.Aptwebstudy.Org
[Recruiting]
San Diego, California, United States, 92121
Contact:Contact: APT Webstudy Team 858-877-3135 info@aptwebstudy.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services