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PET Biomarker Education & Disclosure for Dementia (STIM+ Trial)
N/A
Waitlist Available
Led By Ben Hampstead, PhD
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 change from baseline to immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Awards & highlights
STIM+ Trial Summary
This trial will help researchers understand if people with early signs of dementia can make decisions about their care after being educated about their disease, and how they and their caregivers react to receiving this information.
Who is the study for?
This trial is for individuals with mild cognitive impairment or dementia-Alzheimer's type (DAT) who have completed a PET scan and can make decisions about learning their results, or have a care partner who can. They should not be newly diagnosed with another neurological disease or untreated moderate depression/anxiety.Check my eligibility
What is being tested?
The study aims to see if patients with cognitive issues can understand information about brain changes related to Alzheimer's after education, and how they and their caregivers react when they learn the results from PET scans showing amyloid and tau proteins.See study design
What are the potential side effects?
There are no direct physical side effects from the intervention as it involves education and disclosure of PET scan results. However, there may be emotional or psychological impacts from learning about one's risk of Alzheimer’s.
STIM+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Future Time Perspectives Scale (FTP) Average Score
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score
+8 moreSTIM+ Trial Design
1Treatment groups
Experimental Treatment
Group I: DisclosureExperimental Treatment1 Intervention
Participants who demonstrated decisional capacity for and interest in disclosure (or whose care partner is able to do so) will receive the participant's personalized PET amyloid and tau biomarker status, as well as information about the meaning and clinical utility of this information and recommendations for next steps (e.g., discussing findings with his/her provider).
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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
1,670 Previous Clinical Trials
28,015,014 Total Patients Enrolled
Ben Hampstead, PhDPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own health decisions or have someone who can.I have been diagnosed with a new neurological condition after completing a memory study.I have MCI and a reliable care partner.I have moderate depression or anxiety and am not receiving treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Is this research group currently recruiting participants?
"Clinicaltrials.gov reports that this particular study, created on December 10th 2020 and last edited October 19th 2022, is no longer open for enrolment; however, there are 569 other studies which currently accept participants."
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