> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-extension-for-phase-3-clinical-trials-of-8fc7dab4-9287-4c4f-9aa6-306390f58813 > Record changed: 2026-10-13 # Open-label Extension for Phase 3 Clinical Trials of Simufilam NCT05575076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Participants 1,081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Lead sponsor Cassava Sciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Start date 2022-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) Number of sites 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Short title** Open-label Extension for Phase 3 Clinical Trials of Simufilam Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Official title** An Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Simufilam 100 mg Tablets in Participants With Mild to Moderate Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Reason stopped** sponsor decision Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Dates **Completion date** 2025-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **First posted** 2022-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Registry last updated** 2025-05-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Primary completion date** 2025-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Start date** 2022-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Size and sites **Actual participants** 1,081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Participants** 1,081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Number of sites** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Lead sponsor** Cassava Sciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Identifiers **Registry ID** NCT05575076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **ClinicalTrials.gov ID** NCT05575076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events Timeframe: Baseline to 52 weeks 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 51 Years **Maximum age** 89 Years **Healthy volunteers** No Inclusion Criterion: - Completed RETHINK-ALZ (PTI-125-07) or REFOCUS-ALZ (PTI-125-06). - Clinical presentation continues to be consistent with Alzheimer's disease. - Availability of a study partner. ### Exclusion criteria - Residence in a skilled nursing facility requiring 24-hour care. - Evidence of a neurologic condition other than AD that significantly contributes to the subject's dementia. - Current clinically significant psychiatric diagnosis other than AD. - Unstable, clinically significant medical condition other than AD. - Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Sites - MDFirst ResearchChandler, United States - CCT Research - Gilbert Neurology PartnersGilbert, United States - Xenoscience, Inc.Phoenix, United States - Banner Alzheimer's InstitutePhoenix, United States - Banner Sun Health Research InstituteSun City, United States - Advanced Research Center, Inc.Anaheim, United States - North County Neurology AssociatesCarlsbad, United States - Axiom Research, LLCColton, United States - ATP Clinical Research, Inc.Costa Mesa, United States - Neuro-Pain Medical CenterFresno, United States - Neurology Center of North Orange CountyFullerton, United States - Sun Valley Research Center, Inc.Imperial, United States - Senior Clinical TrialsLaguna Hills, United States - Shankle Clinic and Hoag Memorial Hospital PresbyterianNewport Beach, United States - Artemis Institute for Clinical ResearchRiverside, United States - Pacific Research Network, LLCSan Diego, United States - Syrentis Clinical ResearchSanta Ana, United States - Mountain Neurological Research CenterBasalt, United States - Colorado Neurological Research Center, PCDenver, United States - Ki Health Partners, LLCStamford, United States - JEM Research InstituteAtlantis, United States - Neurology Offices of South FloridaBoca Raton, United States - K2 Medical Research- OcoeeClermont, United States - Arrow Clinical TrialsDaytona Beach, United States - Brain Matters ResearchDelray Beach, United States And 109 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05575076) ## Related records ### Drugs (1) - [Simufilam](https://trialight.com/data/asset/simufilam-bc5cff9c-b790-4165-8b52-9897decc6257.md) ### Lead sponsors (1) - [Cassava Sciences, Inc.](https://trialight.com/data/company/cassava-sciences-inc-cf3e157d-87e8-4e4b-b175-dd231075d5f4.md) ### Conditions (1) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition ### Targets (1) - [FLNA](https://trialight.com/data/target/flna-4b287f5e-49e9-57b5-819e-b4f59359640b.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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