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Risk Disclosure for Mild Cognitive Impairment
N/A
Recruiting
Led By Corey J Bolton, PsyD
Research Sponsored by Vanderbilt University Medical Center
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 immediately following disclosure and at 6-month follow-up
Awards & highlights
Study Summary
This trial is testing whether it is safe to tell people with mild cognitive impairment their risk of Alzheimer's based on their plasma levels of tau phosphorylated at threonine 181 (p-tau181).
Who is the study for?
This trial is for adults aged 60 and older with a diagnosis of amnestic mild cognitive impairment (MCI) from the Vanderbilt Alzheimer's Disease Research Center. They must have someone who interacts with them regularly to participate in study visits, speak English fluently, and be able to consent. Those with major psychiatric or neurological illnesses, significant head injuries, or acute psychological distress are excluded.Check my eligibility
What is being tested?
The study tests how best to inform people about their risk of developing dementia using a new blood test that measures plasma p-tau181 levels compared to standard methods based on age, sex, and cognitive status. Participants will receive educational materials developed by experts and their understanding and emotional well-being will be tracked immediately after disclosure and at six months.See study design
What are the potential side effects?
Since this trial involves risk disclosure rather than medication or invasive procedures, traditional physical side effects are not expected. However, there may be psychological impacts such as anxiety or distress related to learning about one's dementia risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beck Hopelessness Scale
Beck Hopelessness Scale - 6-month follow-up
Geriatric Anxiety Scale
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Plasma p-tau DisclosureExperimental Treatment1 Intervention
To receive risk estimate based on plasma p-tau results in addition to age, sex, and cognitive screening score.
Group II: Standard DisclosureActive Control1 Intervention
To receive risk estimate based on age, sex, and cognitive screening score.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,024 Total Patients Enrolled
Corey J Bolton, PsyDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and make decisions about participating in this study.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Plasma p-tau Disclosure
- Group 2: Standard 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.
Are there any vacancies to join this medical research program?
"As seen on clinicaltrials.gov, this medical trial is presently recruiting study subjects. This research was published on September 1st 2022 and amended two weeks later."
Answered by AI
What is the maximum capacity for participants in this clinical trial?
"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial is currently recruiting participants. The study was initiated on September 1st 2022 and has since been updated as recently as September 14th 2022; 44 individuals are needed from a single site for enrolment in this experiment."
Answered by AI
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