Clinical trial NCT02564692: GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype
Official title: Alzheimer's Prevention Registry GeneMatch Program
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer Disease
Lead sponsor: Banner Health
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 500000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 50 to 90, 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.

Eligibility 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

Primary outcomes:
measure: Number of individuals who enroll in GeneMatch
timeFrame: 15 years
Secondary outcomes:
measure: Number of individuals referred to research studies
timeFrame: 15 years
measure: Number of individuals who enroll in research studies
timeFrame: 15 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
Study officials:
affiliation: Banner Alzheimer's Institute
name: Jessica B Langbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langbaum JB, Karlawish J, Roberts JS, Wood EM, Bradbury A, High N, Walsh TL, Gordon D, Aggarwal R, Davis P, Stowell C, Trisko L, Langlois CM, Reiman EM, Tariot PN. GeneMatch: A novel recruitment registry using at-home APOE genotyping to enhance referrals to Alzheimer's prevention studies. Alzheimers Dement. 2019 Apr;15(4):515-524. doi: 10.1016/j.jalz.2018.12.007. Epub 2019 Feb 13.