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Small Molecule
Long-Term Safety of Simufilam for Alzheimer's Disease
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 52 weeks
Awards & highlights
Summary
This trial looks at how safe a drug is over time for people who have already taken it in a previous trial.
Who is the study for?
This trial is for people who have Alzheimer's Disease and were part of earlier Phase 3 trials called RETHINK-ALZ or REFOCUS-ALZ. Participants need a study partner and must still show symptoms consistent with Alzheimer's. Those in full-time nursing care, with other significant neurological conditions, unstable medical issues, or serious psychiatric diagnoses besides Alzheimer's cannot join.
What is being tested?
The trial is testing the long-term safety and effects of a drug named Simufilam at a dose of 100 mg. It’s an open-label extension, meaning everyone knows they are receiving Simufilam and there’s no placebo group involved.
What are the potential side effects?
While specific side effects for Simufilam aren't listed here, common ones for Alzheimer's treatments can include gastrointestinal issues like nausea or diarrhea, headaches, dizziness, and sometimes more serious reactions depending on individual health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Simufilam 100 mgExperimental Treatment1 Intervention
simufilam 100 mg oral tablet, twice daily
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Who is running the clinical trial?
Cassava Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
2,273 Total Patients Enrolled
Jim Kupiec, MDStudy DirectorCassava Sciences, Inc.
2 Previous Clinical Trials
1,833 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain condition, not Alzheimer's, causing my memory problems.I do not have any unstable health conditions besides Alzheimer's disease.My condition is still showing signs of Alzheimer's disease.My condition is still showing signs of Alzheimer's disease.I have a psychiatric condition other than Alzheimer's disease.You have already participated in the RETHINK-ALZ or REFOCUS-ALZ studies.
Research Study Groups:
This trial has the following groups:- Group 1: Simufilam 100 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- 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: NCT05575076 — Phase 3
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