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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 belowSelect...
You have mild to moderate dementia, with a score between 0.5 and 2 on a global rating scale.
Select...
My condition is in the middle to late stages of Alzheimer's according to specific research criteria.
Select...
My Alzheimer's medication dose has been the same for the last 12 weeks.
Select...
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
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 moreAwards & 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
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.
A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,185 Total Patients Enrolled
Cassava Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
3,123 Total Patients Enrolled
Jim Kupiec, MDStudy ChairCassava Sciences
2 Previous Clinical Trials
2,683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild to moderate dementia, with a score between 0.5 and 2 on a global rating scale.You may not participate if you have already taken part in a study involving an experimental drug for the same condition.My Alzheimer's medication dose has been the same for the last 12 weeks.You have struggled with alcohol or drug addiction in the past two years.My Alzheimer's medication dose has been the same for the last 12 weeks.I am in the middle or late stages of Alzheimer's according to NIA-AA guidelines.You have evidence of Alzheimer's disease pathology, either prior to or during screening.I have had a seizure in the last year.My BMI is between 18.5 and 35.My condition is in the middle to late stages of Alzheimer's according to specific research criteria.You cannot participate if you have previously been in a clinical trial for an experimental drug that targets Alzheimer's disease.I have not smoked for at least 3 years.My diabetes or high blood pressure is not well-controlled.I have a brain condition, not Alzheimer's, that significantly affects my memory.You have a study partner.You must have a mild to moderate level of dementia based on your clinical evaluation score.I have had a stroke or mini-stroke in the last year.I have not had thoughts of suicide in the last 3 months or acted on them in the last year.I have a significant heart condition.You recently had a serious head injury that may be affecting your ability to think clearly.I am currently taking aducanumab.I have not smoked for at least 3 years.I'm sorry, but "Key" is not a clear criterion. Can you please provide more context or information?My BMI is either below 18.5 or above 35.You have a score higher than 8 in a test that measures depression in older adults.My sleep apnea is likely affecting my thinking or memory.You have a mental health condition other than Alzheimer's disease that could affect your ability to complete the study tasks or follow the study guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Simufilam 100 mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 30 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04994483 — Phase 3
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