Risk Disclosure Impact for Alzheimer's Disease

(WeSHARE Trial)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial provides participants with a report predicting their future risk of developing Alzheimer’s disease. It targets people without memory or thinking problems in an aging study. The prediction is made using genetic data, brain scans, blood tests, and demographic information.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What makes this Alzheimer's disease treatment unique?

This treatment is unique because it focuses on disclosing genetic and biomarker information to assess Alzheimer's disease risk, which is not commonly done in standard treatments. It aims to help individuals understand their risk and make informed decisions, despite the challenges and controversies surrounding the predictive value and psychological impact of such information. ^{1 2 3 4 5}

Who Is on the Research Team?

Sarah Hartz, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 65 or older who are part of the Knight Alzheimer Disease Research Center and have been deemed cognitively normal. They must have recent brain scans or blood tests, genetic research results including APOE status, and be open to being contacted for further research.

Inclusion Criteria

Participant is currently consented to be contacted for other research opportunities through the Knight ADRC

I have my genetic test results, including my APOE status.

I've had a brain MRI, PET amyloid scan, or plasma amyloid test in the last 2 years.

Exclusion Criteria

There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Material Review and Informed Consent

Participants review educational materials and sign the informed consent document

2 weeks

1 visit (in-person)

Disclosure of Research Results

Participants receive their research results either two weeks or one year after informed consent, depending on their assigned arm

2 weeks to 1 year

1 visit (in-person or virtual)

Follow-up

Participants are monitored for psychological and behavioral responses to the disclosure of research results

24 months

Multiple assessments at 2, 6, 12, and 24 months post-disclosure

What Are the Treatments Tested in This Trial?

Interventions

• Arm A
• Arm B
• Arm C
• Arm D

Trial Overview The study examines the effects of sharing a five-year risk estimate for developing Alzheimer's disease dementia with participants who currently show no memory or thinking problems in various study arms (Arm A, B, C & D).

How Is the Trial Designed?

Group I: Arm A Active Control 1 Intervention

Participants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm.

Group II: Arm B Active Control 1 Intervention

Participants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm.

Group III: Arm C Active Control 1 Intervention

Participants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm.

Group IV: Arm D Active Control 1 Intervention

Participants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Disclosing Alzheimer's disease risk has traditionally been discouraged due to the limited predictive value of tests and concerns about psychological harm, but interest in risk information is growing, especially with the rise of direct-to-consumer genetic tests.

Research indicates that individuals seeking Alzheimer's risk information through formal education and counseling generally find it beneficial and do not report negative effects, suggesting a potential shift in how risk information could be communicated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating and disclosing the risk of developing Alzheimer's disease: challenges, controversies and future directions. Roberts, JS., Tersegno, SM.[2021]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Family members' perspectives on learning cognitively unimpaired older adults' amyloid-β PET scan results. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Estimating and disclosing the risk of developing Alzheimer's disease: challenges, controversies and future directions. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Predictive genetic testing for Alzheimer's disease: impact upon risk perception. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Moving beyond disclosure: Stages of care in preclinical Alzheimer's disease biomarker testing. [2023]