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Open-label Extension for Phase 3 Clinical Trials of Simufilam

NCT05575076 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1081

Last updated 2025-05-23

Study results available
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Summary

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Simufilam

simufilam 100 mg oral tablet, twice daily

Sponsors & Collaborators

  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • James Kupiec, MD · Cassava Sciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
51 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Puerto Rico
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05575076 on ClinicalTrials.gov