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Completed

NCT Number: NCT05377060

Disclosing Dementia Risk Based on Plasma Phosphorylated Tau

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Illinois, 37212, United States

About this study

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 sensitively and specifically detecting early AD pathology. Plasma p-tau181 has the potential to dramatically reduce the financial strain and patient care burden associated with identifying patients at increased risk of AD-dementia, as well as improve screening for enrollment in clinical trials which require the presence of AD-pathological changes. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Geriatric Depression Scale

    Time frame: Immediately following disclosure

    Questionnaire assessing depression

  2. Geriatric Depression Scale - 6-month follow-up

    Time frame: Immediately following disclosure and at 6-month follow-up

    Questionnaire assessing depression

  3. Geriatric Anxiety Scale

    Time frame: Immediately following disclosure

    Questionnaire assessing anxiety

  4. Geriatric Anxiety Scale - 6-month follow-up

    Time frame: At 6-month follow-up

    Questionnaire assessing anxiety

  5. Beck Hopelessness Scale

    Time frame: Immediately following disclosure

    Questionnaire assessing hopelessness

  6. Beck Hopelessness Scale - 6-month follow-up

    Time frame: At 6-month follow-up

    Questionnaire assessing hopelessness

  7. Impact of Events Scale

    Time frame: At 6-month follow-up

    Questionnaire assessing event-related distress

  8. Immediate Comprehension

    Time frame: Immediately following disclosure

    Semi-structured interview to assess comprehension of disclosure information

  9. Long-term Comprehension

    Time frame: At 6-month follow-up

    Semi-structured interview to assess comprehension of disclosure information

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 17, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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