Together Exploring Aging Minds – An ADNI4 sub-study

OVERVIEW

ADNI plays a central role in improving treatment trials for Alzheimer’s disease. One of the most pressing challenges in the AD field, with immense scientific and ethical ramifications, is the chronic lack of generalizability in research and trial populations, including ADNI. ADNI4’s Together Exploring Aging Minds (TEAM) sub-study aims to address this by enhancing recruitment of individuals who are medically under or uninsured persons, and/or those from lower socioeconomic or educational backgrounds.

ADNI4’s TEAM sub-study aims to recruit and enroll up 200 participants who are:

(1) patients at Health Centers (HCs) such as Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), or Community Health Centers (CHCs), or

(2) individuals who visit/get services at Older Adult Centers (OACs) or Community Centers (CCs) and have 12 or fewer years of education, or

(3) individuals who are recruited by ADNI clinical site study staff (such as at a community outreach event) and have 12 or fewer years of education.

The TEAM-ADNI cohort will complete many of the same procedures that ADNI4 In-Clinic participants undergo. TEAM-ADNI will serve as a feasibility study to recruit and enroll these populations who are largely absent from Alzheimer’s disease research and clinical trials.

STUDY PROCEDURES

(1) Participants will sign an initial screening consent and then answer questions about their background and medical history to assess their eligibility for the full TEAM-ADNI study.

(2) Participants verified as eligible will be invited to the full study.

• Participants recruited from a partner Health Center (FQHC, CHC, RHC) may have the option to complete the study at an ADNI clinical site, or may opt to participate 'Remotely' and complete all assessments over the phone with trained ADNI staff and get a blood draw at their local Quest Diagnostics location.
• Participants recruited from a Community Center/Older Adult Center or via ADNI clinical site outreach efforts will be referred to an ADNI clinical site to participate in the full study.

(3) Participants who enroll in the full TEAM-ADNI study will have the following visit schedule:

• Baseline visit (demographics, medical history, cognitive assessments, optional questionnaires, biofluids collection, optional imaging)
• Quarterly phone check-in calls (month 3, 6, 9)
• Month 12 follow-up visit (repeat cognitive assessments and optional questionnaires)

(4) The TEAM-ADNI assessment battery includes:

• Clinical Dementia Rating Scale (CDR)
• Montreal Cognitive Assessment (MoCA) – Blind version
• Rey Auditory Verbal Learning Test (RAVLT)
• Category Fluency Test: Animals
• Geriatric Depression Scale (GDS)
• Additional required and optional questionnaires and assessments are described in the TEAM-ADNI Protocol

(5) All biofluid collection (blood, plasma, urine) is only collected at baseline. Participants are offered the opportunity to learn results from their clinical labs.

(6) All imaging (MRI; amyloid PET; tau PET) is optional for TEAM-ADNI and only collected at baseline. Participants who opt-in for amyloid PET are offered the opportunity to learn their amyloid PET result.

(7) TEAM-ADNI participants are required to have a study partner will have the following visit schedule:

• Baseline visit
• Month 12 follow-up visit

(8) The TEAM-ADNI study partner assessment battery includes:

• Clinical Dementia Rating Scale (CDR) – Informant version
• Additional required and optional questionnaires and assessments for study partners are described in the TEAM-ADNI Protocol

TEAM-ADNI DATA

• All TEAM-ADNI data will be made available to approved data users (those who have signed a Data Use Agreement and have an active account to access the IDA).
• All TEAM-ADNI participants are assigned a TEAM-ADNI Online ID when they agree/sign the Screening consent.
• Screening data will be made available using the ID format: TEAM-XXX-XXX
• All TEAM-ADNI participants who enroll in the full study will be issued RIDs beginning with 12,000 (PTID format: ###_S_12###)