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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

Study Description
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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
Alzheimer Disease 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Alzheimer Prevention Trials (APT) Webstudy
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638583


Contacts
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Contact: APT Webstudy Team 858-877-3135 info@aptwebstudy.org

Locations
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United States, California
Https://Www.Aptwebstudy.Org Recruiting
San Diego, California, United States, 92121
Contact: APT Webstudy Team    858-877-3135    info@aptwebstudy.org   
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Brigham and Women's Hospital
The Cleveland Clinic
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Paul Aisen, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03638583    
Other Study ID Numbers: HS-17-00746
R01AG053798 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Aisen, University of Southern California:
Alzheimer's
Prevention
Web-Based
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders