Disclosing Dementia Risk Based on Plasma Phosphorylated Tau

NCT05377060 | Completed

• 1 other identifier: 220449
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (9)

• Geriatric Depression Scale

  Questionnaire assessing depression

  Immediately following disclosure

• Geriatric Depression Scale - 6-month follow-up

  Questionnaire assessing depression

  Immediately following disclosure and at 6-month follow-up

• Geriatric Anxiety Scale

  Questionnaire assessing anxiety

  Immediately following disclosure

• Geriatric Anxiety Scale - 6-month follow-up

  Questionnaire assessing anxiety

  At 6-month follow-up

• Beck Hopelessness Scale

  Questionnaire assessing hopelessness

  Immediately following disclosure

• Beck Hopelessness Scale - 6-month follow-up

  Questionnaire assessing hopelessness

  At 6-month follow-up

• Impact of Events Scale

  Questionnaire assessing event-related distress

  At 6-month follow-up

• Immediate Comprehension

  Semi-structured interview to assess comprehension of disclosure information

  Immediately following disclosure

• Long-term Comprehension

  Semi-structured interview to assess comprehension of disclosure information

  At 6-month follow-up

Study Arms (2)

Plasma p-tau Disclosure

EXPERIMENTAL

To receive risk estimate based on plasma p-tau results in addition to age, sex, and cognitive screening score.

Behavioral: Plasma p-tau risk disclosure

Standard Disclosure

ACTIVE COMPARATOR

To receive risk estimate based on age, sex, and cognitive screening score.

Behavioral: Standard risk disclosure

Interventions

Plasma p-tau risk disclosure BEHAVIORAL

Participants will receive an estimated risk for converting to dementia in the next four years based on age, sex, MMSE score, and plasma p-tau results.

Plasma p-tau Disclosure

Standard risk disclosure BEHAVIORAL

Participants will receive an estimated risk for converting to dementia in the next four years based on age, sex, and MMSE score.

Standard Disclosure

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants recruited will include 62 adults aged 60 and older.
• Consensus diagnosis of amnestic MCI by Vanderbilt Alzheimer's Disease Research Center (VADRC) clinician panel.
• Availability of a reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person).
• English language fluency.

You may not qualify if:

• Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study.
• History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness.
• Presence of acute psychological distress (i.e., Geriatric Depression Scale \>10 at screening).
• Participation in other risk disclosure protocols.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Illinois, 37212, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Corey J Bolton, PsyD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 17, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)