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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer's Disease

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer's Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs Simufilam (Primary)
  • Indications Alzheimer's disease; Dementia
  • Focus Registrational; Therapeutic Use
  • Acronyms REFOCUS-ALZ
  • Sponsors Cassava Sciences

    • Most Recent Events

    • 08 Aug 2024 According to a Cassava Sciences media release, over 555 patients have completed the 52-week RETHINK-ALZ study. Over 420 patients have completed the 76-week REFOCUS-ALZ study, for a total of over 975 completers.
    • 10 May 2024 According to a Cassava Sciences media release, top-line data readout for our 76-week study (REFOCUS-ALZ) is anticipated in mid-year 2025.
    • 25 Mar 2024 According to a Cassava Sciences media release, the company announced the completion of another interim patient safety review by an Independent Data and Safety Monitoring Board (DSMB). DSMB recommended that trial continue as planned, without modification.

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