Disclosing dementia risk using blood tests

Disclosing Dementia Risk Based on Plasma Phosphorylated Tau

This study is trying to see if sharing blood test results about dementia risk can help people with mild cognitive impairment understand their condition better and prepare for the future.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Illinois)
• Trial ID: NCT05377060 on ClinicalTrials.gov

What this trial studies

This study aims to develop and evaluate educational materials for disclosing dementia risk based on plasma levels of phosphorylated tau (p-tau181) in individuals with mild cognitive impairment (MCI). It will involve creating comprehensible resources in collaboration with health communication experts and refining them through focus groups. The study will assess the impact of this risk disclosure on participants who are at imminent risk of progressing to dementia. By utilizing a novel blood-based biomarker, the research seeks to enhance early detection and improve patient care strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 60 and older with a consensus diagnosis of amnestic mild cognitive impairment.

Not a fit: Patients who lack decisional capacity to provide informed consent or have significant psychiatric or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective way to inform patients about their risk of developing Alzheimer's disease.

How similar studies have performed: Previous studies on risk disclosure based on genetic and amyloid status have shown safety, but this approach using p-tau181 is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Participants recruited will include 62 adults aged 60 and older.
2. Consensus diagnosis of amnestic MCI by Vanderbilt Alzheimer's Disease Research Center (VADRC) clinician panel.
3. 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).
4. English language fluency.

Exclusion Criteria:

1. Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study.
2. 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.
3. Presence of acute psychological distress (i.e., Geriatric Depression Scale \>10 at screening).
4. Participation in other risk disclosure protocols.

Where this trial is running

Nashville, Illinois

• Vanderbilt University Medical Center — Nashville, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Corey J Bolton, PsyD — Vanderbilt University Medical Center
• Study coordinator: Corey J Bolton, PsyD

Conditions Alzheimer Disease; Mild Cognitive Impairment