What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Dementia include cholinesterase inhibitors (such as donepezil and galantamine), memantine, aducanumab, and vitamin E. Cholinesterase inhibitors can cause gastrointestinal issues, muscle cramps, and insomnia. Memantine is generally well-tolerated but may cause dizziness, headache, and constipation. Aducanumab has been associated with amyloid-related imaging abnormalities (ARIA), headache, falls, diarrhea, and confusion. Vitamin E is considered safe with a good tolerability profile, though its benefits are modest. These treatments aim to manage symptoms but come with varying side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Dementia, including cholinesterase inhibitors such as donepezil and galantamine, which help improve cognitive function by increasing levels of acetylcholine in the brain. Memantine, an NMDA receptor antagonist, is also approved and works by regulating glutamate activity to prevent neuronal damage. Additionally, a combination therapy of memantine and donepezil is available. While not specifically FDA-approved for Alzheimer's, vitamin E has been studied for its potential benefits in slowing disease progression due to its antioxidant properties.

What other types of research exist?

Promising novel alternatives to communicating risk estimates for Alzheimer's Dementia patients include: 1) Utilizing predictive biomarkers such as amyloid PET scans and cerebrospinal fluid analysis to provide more personalized risk assessments. 2) Implementing neuroprotective strategies like intense aerobic exercise, which has shown potential in reducing neurodegeneration risk. 3) Engaging in collaborative clinical trials through consortia like the International Rapid Eye Movement Sleep Behavior Disorder Study Group to explore disease-modifying therapies. 4) Providing comprehensive patient education materials that balance detailed information with accessibility, tailored to individual patient needs and preferences.

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Risk Disclosure Impact for Alzheimer's Disease (WeSHARE Trial)

N/A

Waitlist Available

Led By Sarah Hartz, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has genetic research results available including APOE status

Minimum age of 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-disclosure of risk estimate

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since this trial involves returning personal health risk information rather than medical treatments, traditional physical side effects are not applicable. However, receiving such information may have psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 65 years old or older.

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I am a current participant of the Knight ADRC and had my clinical assessment last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-disclosure of risk estimate

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-disclosure of risk estimate

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-disclosure of risk estimate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Impact of Events Scale (IES)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Arm AActive Control1 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 BActive Control1 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 CActive Control1 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 DActive Control1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Dementia include cholinesterase inhibitors and memantine. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase levels of acetylcholine in the brain by inhibiting its breakdown, which can help improve memory and learning. Memantine works by regulating glutamate activity to prevent neuronal damage. These treatments are important as they can provide symptomatic relief and improve the quality of life for patients, even though they do not alter the disease's progression.

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