What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, galantamine) and memantine, have known side effects. Cholinesterase inhibitors can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, and insomnia. Memantine may lead to dizziness, headache, confusion, and constipation. These treatments aim to improve cognitive function and slow disease progression, similar to the goals of Simufilam, which is being studied for its potential to stabilize neuronal function and reduce neuroinflammation.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, focusing on different mechanisms to manage symptoms and slow disease progression. Notably, aducanumab, an amyloid beta-directed antibody, was approved to reduce amyloid plaques in the brain, which is believed to slow cognitive decline. Other treatments include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which aim to improve neurotransmitter function, and memantine, an NMDA receptor antagonist that helps regulate glutamate activity to protect neurons. While these treatments differ in their specific mechanisms, they share the common goal of enhancing neuronal function and reducing neuroinflammation, similar to the therapeutic aims of Simufilam.

What other types of research exist?

Promising novel alternatives to Simufilam for Alzheimer's Disease patients in 2024 include: 1) Lecanemab, an anti-amyloid beta protofibril antibody that has shown efficacy in reducing amyloid plaques and slowing cognitive decline. 2) Donanemab, another anti-amyloid antibody targeting a different epitope of amyloid beta, which has demonstrated potential in early clinical trials. 3) ALZ-801, an oral agent that inhibits amyloid formation by stabilizing soluble amyloid oligomers. These therapies represent different approaches to modifying disease progression and improving cognitive function in AD patients.

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Simufilam for Alzheimer's Disease (RETHINK-ALZ Trial)

Phase 3

Waitlist Available

Research Sponsored by Cassava Sciences, Inc.

Eligibility Criteria Checklist

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

Must have

Clinical Dementia Rating - Global Score must be 0.5, 1 or 2.

Meets National Institute on Aging and Alzheimer's Association Research Framework criteria for individuals in clinical Stage 4 or 5 of the Alzheimer's continuum.

Timeline

Screening 30 weeks

Treatment 6 months

Follow Up 6 months

Awards & highlights

Pivotal Trial

Summary

This trial tests simufilam, a pill taken twice daily, on people with mild-to-moderate Alzheimer's disease. The goal is to see if it can improve memory and slow down the worsening of symptoms by helping the brain work better and reducing harmful swelling. The study will last for about a year and involve periodic check-ups to monitor safety and effectiveness.

Who is the study for?

This trial is for adults with mild-to-moderate Alzheimer's Disease who have been stable on current AD medications for at least 12 weeks, have a certain range of cognitive function scores, and haven't smoked in 3+ years. They need a study partner and can't join if they've had recent seizures or strokes, uncontrolled diabetes or hypertension, severe psychiatric conditions, specific BMI limits, or are taking certain other AD drugs.

What is being tested?

The study tests the safety and effectiveness of Simufilam (100 mg) compared to a placebo over one year. Participants will take the drug twice daily and attend clinic visits every few months to assess changes in cognition and ability to perform daily activities.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions common in Alzheimer's treatments such as gastrointestinal issues (nausea), headaches, dizziness, insomnia or sleep disturbances. Specific side effects related to Simufilam will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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You have mild to moderate dementia, with a score between 0.5 and 2 on a global rating scale.

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My condition is in the middle to late stages of Alzheimer's according to specific research criteria.

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My Alzheimer's medication dose has been the same for the last 12 weeks.

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You cannot participate if you have previously been in a clinical trial for an experimental drug that targets Alzheimer's disease.

Timeline

Screening ~ 30 weeks8 visits

Treatment ~ 6 months7 visits

Follow Up ~ 6 months1 visit

Screening ~ 30 weeks

Treatment ~ 6 months

Follow Up ~6 months

This trial's timeline: 30 weeks for screening, 6 months for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alzheimer's Disease

Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

Secondary study objectives

Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)

Change from baseline in the Mini-Mental State Exam (MMSE)

Change from baseline in the Neuropsychiatric Inventory (NPI)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Simufilam 100 mgExperimental Treatment1 Intervention

Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks

0 / 6Eligibility 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

Common treatments for Alzheimer's Disease (AD) primarily include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby improving cognitive function. NMDA receptor antagonists protect neurons from excessive glutamate, which can cause excitotoxicity and neuronal damage. Emerging treatments like Simufilam aim to stabilize Filamin A, a protein that, when altered, disrupts neuronal function and increases neuroinflammation. By restoring Filamin A's normal function, Simufilam may reduce neuroinflammation and improve neuronal health, offering a novel approach to managing AD symptoms. These mechanisms are crucial as they target different aspects of the disease pathology, potentially slowing cognitive decline and improving quality of life for AD patients.

A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.