Plasma p-tau Disclosure for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vanderbilt University Medical Center, Nashville, IL
Alzheimer Disease+3 More
Plasma p-tau risk disclosure - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in detecting early AD pathology. While current studies point to this biomarker as having great clinical utility, one necessary step before clinical implementation is developing safe and effective methods for disclosure of results. Past risk disclosure studies have shown that disclosing risk for AD based on genetics or amyloid status is safe, but these studies have largely focused on cognitively unimpaired individuals. This study seeks to develop comprehensible educational materials to aid risk disclosure and examine the effect of risk disclosure based on plasma p-tau181 results in a group of participants with mild cognitive impairment (MCI) at imminent risk of converting to dementia. First, educational materials will be developed in collaboration with health communication experts and then refined in focus groups made up of individuals with MCI. Educational materials will be analyzed on several key reading and comprehensibility metrics and will include personalized risk estimate based on a well-accepted risk algorithm (Cullen, et al., 2021). Next, these educational materials will be utilized to disclose risk in a randomized controlled trial with an active control arm receiving disclosure based on age, sex, and cognitive status (based on Mini-Mental State Examination), meant to mimic common methods of clinical diagnostic and prognostic decision making, and an intervention arm receiving disclosure based on the above factors plus plasma p-tau181 results. Outcomes will include measures of comprehension and psychological well-being (anxiety, depression, hopelessness, and distress) and will be assessed immediately after risk disclosure and again at six-month follow-up. It is hypothesized that risk disclosure based on plasma p-tau181 is not more psychologically harmful or less comprehensible than disclosure based on demographic factors and MMSE. This pilot study will provide a necessary step towards moving plasma p-tau biomarkers towards safe clinical implementation and will develop educational materials that can be utilized in future studies and clinical practice.

Eligible Conditions

  • Alzheimer Disease
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer Disease

Study Objectives

9 Primary · 0 Secondary · Reporting Duration: At 6-month follow-up

At 6-month follow-up
Beck Hopelessness Scale - 6-month follow-up
Geriatric Anxiety Scale - 6-month follow-up
Impact of Events Scale
Long-term Comprehension
Immediately following disclosure
Beck Hopelessness Scale
Geriatric Anxiety Scale
Geriatric Depression Scale
Immediate Comprehension
Immediately following disclosure and at 6-month follow-up
Geriatric Depression Scale - 6-month follow-up

Trial Safety

Safety Progress

1 of 3

Other trials for Alzheimer Disease

Trial Design

2 Treatment Groups

Standard Disclosure
1 of 2
Plasma p-tau Disclosure
1 of 2
Active Control
Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Plasma p-tau Disclosure · No Placebo Group · N/A

Plasma p-tau Disclosure
Behavioral
Experimental Group · 1 Intervention: Plasma p-tau risk disclosure · Intervention Types: Behavioral
Standard Disclosure
Behavioral
ActiveComparator Group · 1 Intervention: Standard risk disclosure · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6-month follow-up

Trial Background

Corey Bolton, MD
Principal Investigator
Vanderbilt University Medical Center
Closest Location: Vanderbilt University Medical Center · Nashville, IL
Photo of vanderbilt university medical center  1Photo of vanderbilt university medical center  2Photo of vanderbilt university medical center  3
2006First Recorded Clinical Trial
14 TrialsResearching Alzheimer Disease
1019 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a consensus diagnosis of amnestic MCI by a VADRC clinician panel.
You have limited English language fluency.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.