Phase 3 Alzheimer's Disease Trial, Terminated NCT05575076 Sponsor: Cassava Sciences, Inc. Condition: Alzheimer's Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,081 people who had previously completed one of two earlier simufilam studies. All participants received simufilam at a dose of 100 mg. The trial was an open-label extension study, meaning everyone received the same treatment with no placebo comparison group. Of the 1,081 people who started, 300 completed the study and 781 did not complete it. The main thing the trial was set up to measure was how many participants experienced adverse events (that is, any unwanted or unexpected medical occurrences) over the longer term while taking simufilam. The reported data shows that in the group taking simufilam 100 mg, four separate counts of participants experiencing adverse events were recorded. The figures reported were 299, 198, 63, and 519 participants respectively across these categories. However, the data as submitted to ClinicalTrials.gov does not include labels clearly describing what each of these four numbers specifically refers to (for example, whether they represent mild, moderate, or severe events, or other subcategories), so it is not possible to describe each figure in further detail without risking misrepresentation. The trial did not report any secondary outcome measure data in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Alzheimer's Disease Trial, Terminated

NCT05575076
Terminated Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You must have already completed one of two specific earlier studies called RETHINK-ALZ or REFOCUS-ALZ.
  • You still show signs and symptoms that are consistent with Alzheimer's disease.
  • You have a study partner (such as a family member or caregiver) who is available to take part alongside you.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You currently live in a skilled nursing facility where you need round-the-clock care.
  • You have another brain or nervous system condition (separate from Alzheimer's) that is also significantly contributing to your memory or thinking problems.
  • You currently have a significant mental health diagnosis other than Alzheimer's disease.
  • You have another serious medical condition (unrelated to Alzheimer's) that is not stable or well-controlled.
  • You have any medical condition that the study doctor feels could affect your safety or your ability to complete the trial (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 August 2026

Trial contact details on record

Principal Investigator: James Kupiec, MD, Cassava Sciences, Inc.

Australian sites

KaRa Institute of Neurological Diseases Pty. Ltd., Macquarie Park, New South Wales
The University of Queensland, Herston, Queensland
Delmont Consulting Suites, Glen Iris, Victoria
Austin Health, Heidelberg, Victoria
The Alfred Hospital, Melbourne, Victoria
Eastern Health, Melbourne, Victoria
Alzheimer's Research Australia, Nedlands, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Cassava Sciences, Inc.
Registry
ClinicalTrials.gov
Start date
7 November 2022
Est. completion
31 January 2025

Where this trial was run

🇦🇺 Australia 🇨🇦 Canada Puerto Rico 🇰🇷 South Korea 🇺🇸 United States

These are the locations recorded on the registry, including 7 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Number of Participants With Adverse Events

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov