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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
No Placebo-Only Group
Pivotal Trial

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 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 52 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

Awards & Highlights

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Simufilam 100 mgExperimental Treatment1 Intervention
simufilam 100 mg oral tablet, twice daily

Find a Location

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

Media Library

Simufilam (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05575076 — Phase 3
Alzheimer's Disease Research Study Groups: Simufilam 100 mg
Alzheimer's Disease Clinical Trial 2023: Simufilam Highlights & Side Effects. Trial Name: NCT05575076 — Phase 3
Simufilam (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05575076 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05575076 — Phase 3
~764 spots leftby Jul 2026
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