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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Dec 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

    • 25 Nov 2024 Status changed from active, no longer recruiting to discontinued as per a Cassava Sciences media release.
    • 25 Sep 2024 According to a Cassava Sciences media release, the company announced the completion of a third interim patient safety review by an Independent Data and Safety Monitoring Board (DSMB). DSMB recommended that trial continue as planned, without modification. Final safety data are expected at the conclusion of the Phase 3 program.
    • 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.

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