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NCT05377060 · ClinicalTrials.gov registry record · NA
Disclosing Dementia Risk Based on Plasma Phosphorylated Tau
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT05377060 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 28 participants.
The verdict
NCT05377060, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
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 demo
Interventions
- BEHAVIORAL Plasma p-tau risk disclosure
- BEHAVIORAL Standard risk disclosure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05377060
The ClinicalTrials.gov registry entry for NCT05377060 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Plasma p-tau risk disclosure is the first listed.
NCT05377060 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05377060 about?
NCT05377060 is a clinical study titled "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 clini...
What is the current status of trial NCT05377060?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2022-09-01. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT05377060?
The interventions under investigation include: Plasma p-tau risk disclosure (BEHAVIORAL), Standard risk disclosure (BEHAVIORAL).
Who is sponsoring clinical trial NCT05377060?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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