Clinical trial NCT05584241: Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure
Official title: Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Amnestic Mild Cognitive Disorder
Keywords: AD Biomarkers
Alzheimer's Disease
Mild Cognitive Impairment
Amnestic Mild Cognitive Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized delayed start design. Participants are randomized to receive, at baseline, either 'Diagnostic Disclosure Protocol' (cognitive testing/diagnosis) with an option to receive biomarker results after 6 months or 'Biomarker Disclosure Protocol' (cognitive testing, diagnosis, positron emission tomography-based amyloid and tau imaging. They are further categorized by biomarker status (+/positive or -/negative) for reporting purposes.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
* Available PET Aβ and tau imaging

Exclusion Criteria:

* Significant neurologic diagnosis (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
* Neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness \> 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention)
* Motor abnormalities indicative of a non-AD etiology
* Severe mental illness (e.g., bipolar disorder, psychosis), moderate-severe mood or anxiety disorder, active substance use disorder (o reduce the likelihood of severe psychological distress, participants must screen negative for moderate-severe depressive or anxiety symptoms at study enrollment.)
* Inability to provide independent informed consent.

Primary outcomes:
measure: Post-disclosure health behavior change as measured by the health behavior subscale score
timeFrame: 6 months
measure: Post-disclosure health behavior change as measured by the health communication subscale score
timeFrame: 6 months
measure: Post-disclosure health behavior change as measured by the advanced planning subscale score
timeFrame: 6 months
measure: Post-disclosure health behavior change as measured by the research engagement subscale score
timeFrame: 6 months
measure: Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Annalise Rahman-Filipiak
role: PRINCIPAL_INVESTIGATOR
References: