What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, have well-documented side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine is generally well-tolerated but can cause dizziness, headache, confusion, and constipation. Both classes of drugs aim to improve cognitive function and reduce neuroinflammation, similar to the investigational drug Simufilam.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease that aim to modulate neuronal function and reduce neuroinflammation. Notable among these is aducanumab, which targets amyloid-beta plaques to slow disease progression. Another example is donepezil, an acetylcholinesterase inhibitor that enhances cholinergic function. While these drugs differ in their specific mechanisms, they share the common goal of improving neuronal function and mitigating neuroinflammation, akin to the investigational drug Simufilam, which modulates Filamin A.

What other types of research exist?

Promising novel alternatives to Simufilam for Alzheimer's Disease patients include: 1) Lecanemab, an anti-amyloid beta protofibril antibody that has shown to reduce amyloid plaques and slow cognitive decline. 2) Donanemab, another anti-amyloid antibody targeting a different epitope of amyloid beta, which has demonstrated potential in slowing disease progression. 3) Aducanumab, an anti-amyloid beta monoclonal antibody approved by the FDA, aimed at reducing amyloid plaques in the brain. These treatments represent significant advancements in targeting the underlying pathology of Alzheimer's Disease.

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Small Molecule

Simufilam for Alzheimer's Disease

Phase 2

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

• Subjects must have completed the PTI-125-04 study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 96 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves patients with mild-to-moderate Alzheimer's disease taking simufilam regularly. It aims to see if the medication is safe and effective over time. Simufilam works by targeting proteins in the brain that are associated with Alzheimer's.

Who is the study for?

This clinical trial is open to individuals with mild-to-moderate Alzheimer's Disease who have completed the PTI-125-04 study. It's designed to assess long-term treatment effects and safety over a period of 96 weeks.

What is being tested?

The trial is testing simufilam, given at a dose of 100 mg twice daily (b.i.d.). The focus is on understanding its safety and effectiveness when used over an extended time in those previously involved in the initial Phase 2 study.

What are the potential side effects?

Potential side effects include reactions commonly associated with medications such as changes in lab results, urine abnormalities, altered vital signs, heart-related issues seen on ECGs, and any adverse events that may be reported.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 96 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Event Monitoring

Secondary study objectives

NPI

Side effects data

From 2021 Phase 1 trial • 24 Patients • NCT04932655

headache

Myalgia

fatigue

diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Phase 3 High-fat Fed Simufilam

Phase 3 Low-fat Fed Simufilam

Fasted Phase 2 Simufilam

Fasted Phase 3 Simufilam

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Simufilam 100 mgExperimental Treatment1 Intervention

simufilam 100 mg oral tablets, b.i.d.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

simufilam

2021

Completed Phase 1

~30

0 / 1Eligibility 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 focus on modulating neurotransmitter activity and reducing neuroinflammation. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby improving cognitive function. NMDA receptor antagonists (e.g., memantine) help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Emerging treatments like Simufilam target the protein Filamin A to restore neuronal function and reduce neuroinflammation, addressing underlying disease mechanisms. These approaches are crucial as they aim to slow disease progression and improve quality of life for AD patients by targeting both symptoms and root causes.

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