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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
Must not have
Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following disclosure and at 6-month follow-up
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and make decisions about participating in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Beck Hopelessness Scale
Beck Hopelessness Scale - 6-month follow-up
Geriatric Anxiety Scale
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
907 Previous Clinical Trials
934,543 Total Patients Enrolled
Corey J Bolton, PsyDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Plasma p-tau risk disclosure Clinical Trial Eligibility Overview. Trial Name: NCT05377060 — N/A
Alzheimer's Disease Research Study Groups: Plasma p-tau Disclosure, Standard Disclosure
Alzheimer's Disease Clinical Trial 2023: Plasma p-tau risk disclosure Highlights & Side Effects. Trial Name: NCT05377060 — N/A
Plasma p-tau risk disclosure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377060 — N/A
~7 spots leftby May 2025
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