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NCT05575076 · ClinicalTrials.gov registry record · Phase 3

Open-label Extension for Phase 3 Clinical Trials of Simufilam

A Phase 3 study, sponsored by Cassava Sciences.

Terminated
Registry status
Phase 3
Development phase
1,081
Enrollment target

NCT05575076: Clinical Trial Phase 3 study, sponsored by Cassava Sciences.

NCT05575076 is a Phase 3 study that was terminated before completion, run by Cassava Sciences. The registered enrollment target is 1,081 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05575076, a Phase 3 study, was terminated before completion, sponsored by Cassava Sciences.

TERMINATED
Registry status
Phase 3
Development phase
1,081 participants
Enrollment target

Study 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.

Primary Outcome

To evaluate the long-term safety and tolerability of simufilam 100 mg tablets in subjects who have completed one of the two double-blind simufilam phase 3 studies.

Interventions

  • DRUG Simufilam

Trial Details

FieldValue
Enrollment Target 1,081 participants
Start Date 2022-11-07
Est. Completion 2025-01-31
Phase Phase 3
Cassava Sciences

9 total trials

Why NCT05575076 stopped before completion

NCT05575076 is an interventional study that assigns participants to a tested intervention. Its 1,081 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher).

The record links to 0 conditions, and to 1 intervention - of which Simufilam is the first listed.

NCT05575076 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05575076 about?

NCT05575076 is a clinical study titled "Open-label Extension for Phase 3 Clinical Trials of Simufilam". 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.

What is the current status of trial NCT05575076?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,081 participants. The study started on 2022-11-07. Estimated completion is 2025-01-31.

What interventions are being tested in trial NCT05575076?

The interventions under investigation include: Simufilam (DRUG).

Who is sponsoring clinical trial NCT05575076?

This trial is sponsored by Cassava Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05575076's enrollment target sits among peer trials

1,081 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05575076, the US trial registry maintained by the National Library of Medicine. NCT05575076 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.