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GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype

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ClinicalTrials.gov Identifier: NCT02564692
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Jessica Langbaum, PhD, Banner Health

Study Description
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Brief Summary:
The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large group of people interested in participating in research studies or clinical trials based in part on their genetic background. This genetic information will be used to match interested individuals to studies, providing a recruitment resource to the Alzheimer's scientific community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the GeneMatch program.

Condition or disease
Alzheimer Disease

Detailed Description:
The primary objectives of the Alzheimer's Prevention Registry GeneMatch program are to (1) identify and characterize a large cohort of people who are interested in, and may be eligible to participate in, current and future preclinical Alzheimer's disease research studies and clinical trials based on their genetic background, and (2) provide information to these individuals about research studies for which they may be eligible, based in part on their genetic background. Cognitively unimpaired individuals age 55 to 75, inclusive, are eligible to enroll in GeneMatch. GeneMatch will provide participants with a genetic sample kit (a cheek swab) to test for a specific gene called apolipoproteins E (APOE). GeneMatch does not disclose the results of the APOE test to participants. GeneMatch may use the APOE test results to match participants to research studies. Participants are under no obligation to pursue these study opportunities.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Alzheimer's Prevention Registry GeneMatch Program
Study Start Date : November 2015
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of individuals who enroll in GeneMatch [ Time Frame: 15 years ]

Secondary Outcome Measures :
  1. Number of individuals referred to research studies [ Time Frame: 15 years ]
  2. Number of individuals who enroll in research studies [ Time Frame: 15 years ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This large research study will ultimately enroll 500,000 adults. We will recruit subjects from all over the United States, as everything is done via email, mail, or/and phone.
Criteria

Inclusion Criteria:

  • Age 50-90, inclusive
  • Provide basic demographic, medical history, and contact information
  • Consent to APOE genotyping without receiving results
  • Live in the United States

Exclusion Criteria:

  • Unable to comply with this project's protocol requirements
  • Self-reported diagnosis of dementia or any other objective cognitive impairment syndrome
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): NCT02564692


Locations
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Sponsors and Collaborators
Banner Health
Investigators
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Principal Investigator: Jessica B Langbaum, PhD Banner Alzheimer's Institute
More Information
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Additional Information:

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Responsible Party: Jessica Langbaum, PhD, Director, Alzheimer's Prevention Initiative, Banner Health
ClinicalTrials.gov Identifier: NCT02564692    
Other Study ID Numbers: APR-001
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
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