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Biomarker Disclosure for Alzheimer's Disease (SHARED III Trial)
N/A
Waitlist Available
Led By Annalise Rahman-Filipiak
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
SHARED III Trial Summary
This trial will assess how Black & White patients with aMCI adjust lifestyle/health after learning their risk of dementia & Alzheimer's. Healthcare access will be studied as a factor.
Who is the study for?
This trial is for Black and White patients recently diagnosed with Amnestic Mild Cognitive Impairment (aMCI) who have undergone PET scans showing amyloid and tau proteins. It's not suitable for those with severe neurological diagnoses, significant neurologic injury, motor abnormalities not due to AD, severe mental illness, or active substance use disorders.Check my eligibility
What is being tested?
The study examines the impact of informing participants about their brain imaging results that show markers of Alzheimer's disease. It looks at how this knowledge might change their health behaviors, planning for the future, and willingness to participate in research.See study design
What are the potential side effects?
Since this trial involves disclosure of diagnostic information rather than medication or procedures, traditional side effects are not applicable. However, learning one's biomarker status could potentially lead to emotional responses like anxiety or distress.
SHARED III Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
Post-disclosure health behavior change as measured by the advanced planning subscale score
Post-disclosure health behavior change as measured by the health behavior subscale score
+2 moreSHARED III Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker and Diagnostic DisclosureExperimental Treatment1 Intervention
Participants receive information about their cognitive test results and research diagnosis. In addition, participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging. PET is a type of imaging biomarker (Aß-PET and tau PET) for clinical diagnosis of Alzheimer's disease. These actions are followed by post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
Group II: Diagnostic DisclosureActive Control1 Intervention
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,836 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,005,014 Total Patients Enrolled
Annalise Rahman-FilipiakPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have major neurological conditions like Alzheimer's, Parkinson's, seizures, tumors, or MS.I cannot give consent on my own due to my condition.I was diagnosed with memory loss affecting my daily life within the last year.I have had a serious brain injury or stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic Disclosure
- Group 2: Biomarker and Diagnostic Disclosure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have availability for new participants?
"According to clinicaltrials.gov, this experiment is no longer recruiting patients - it was posted on November 1st, 2022 and last modified on October 13th of the same year. Nevertheless, there are still 998 other studies that are currently welcoming participants."
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