Risk Disclosure Impact for Alzheimer's Disease

(WeSHARE Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how sharing Alzheimer's disease risk information affects healthy individuals. Participants are divided into four groups (Arm A, Arm B, Arm C, Arm D). Some receive their brain scan or blood test results either two weeks or one year after reviewing educational materials. The trial includes individuals who have been evaluated at the Knight Alzheimer Disease Research Center, are at least 65 years old, have no memory issues, and possess recent brain imaging or blood test results. As an unphased trial, it offers participants the chance to contribute to important research that could influence future Alzheimer's disease prevention strategies.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sharing brain scan results with individuals without memory problems is usually safe. One study found no increase in depression and only a brief rise in anxiety, which subsided within six weeks. Another study supported this, showing that most people handle learning about their amyloid status (a sign of Alzheimer's) well.

For blood tests revealing amyloid levels, research also indicates safety. One study found no change in depression or memory concerns after individuals learned their amyloid status. Anxiety and the desire to improve lifestyle even decreased slightly.

Both methods of sharing results appear well-accepted, with only minor, temporary increases in anxiety reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk Disclosure Impact for Alzheimer's Disease trial because it examines how quickly participants receive their research results, potentially impacting patient care and decision-making. Unlike standard diagnostic methods which can take time and often don't involve patient education, this trial explores the effects of immediate versus delayed result disclosure after educational interventions. This could lead to a better understanding of how information timing affects patient anxiety and engagement, ultimately optimizing Alzheimer's care protocols.

What evidence suggests that this trial's treatments could be effective?

This trial will compare different approaches to disclosing research results related to Alzheimer's disease. Participants in Arm A and Arm B will receive neuroimaging results, with Arm A receiving results two weeks after reviewing educational materials and Arm B receiving results one year later. Research has shown that brain scans can reveal how the brain changes over time, enhancing understanding of Alzheimer's disease. Tracking these changes can improve predictions of disease progression, aiding in planning future treatments and care.

Participants in Arm C and Arm D will receive plasma amyloid results, with Arm C receiving results two weeks after reviewing educational materials and Arm D receiving results one year later. Recent studies suggest that certain blood tests can be over 92% accurate in detecting changes related to Alzheimer's. These tests measure specific proteins in the blood, providing important insights into the risk and progression of the disease. Both brain scans and blood tests offer promising ways to better understand Alzheimer's and may help guide future treatment decisions. ^{2 5 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417339/

Recent advances in neuroimaging of Alzheimer's disease and ... This review covers recent advances (2023–2024) in neuroimaging research into the pathophysiology, progression, and treatment of Alzheimer's ...

2. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70081

Measuring time saved in Alzheimer's disease: What is a ... Highlights · AD slowing of clinical progression by 5%–95% resulted in 0.74–17 months saved and 0.08–1.5 CDR-SB points change at 18 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10883638/

A pragmatic, investigator-driven process for disclosure of ... The Alzheimer's Disease Neuroimaging Initiative (ADNI) is formally incorporating amyloid PET disclosure into the newest protocol (ADNI-4).

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.14365

Counseling and disclosure practices in predictive Alzheimer's ... New possibilities of biomarker-based predictive technologies for Alzheimer's disease (AD) have become more reliable and also more accessible.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723022819

Neuroimaging outcomes in clinical trials in Alzheimer's ... Progression of atrophy on MR-based structural imaging is the most extensively validated surrogate outcome for trials of disease modifying drugs in AD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5582024/

Safety of Disclosing Amyloid Status in Cognitively Normal ... Results showed no effect on depressive symptoms and a small peak in anxiety symptoms on the day of disclosure that was not sustained 6-weeks and 6-months later.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724000761

A Pragmatic, Investigator-Driven Process for Disclosure of ... Prior studies of Alzheimer's disease (AD) biomarker disclosure have answered important questions about individuals' safety after learning and comprehending ...

8. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2769022

Short-term Psychological Outcomes of Disclosing Amyloid ... In this study, in the short term, amyloid imaging results were safely disclosed to older adults who did not have cognitive impairment.