TerminatedPhase 3Results posted

Open-label Extension for Phase 3 Clinical Trials of Simufilam

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

Lead sponsor

Cassava Sciences, Inc.

Asset

Simufilam

Listed sites

134

Recruiting sites

Enrollment

1,081

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 51-89

Primary endpoint

•Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05575076

Org study IDPTI-125-10

Timeline

Milestones

Study first posted2022-10-12actual

Study start2022-11-07actual

Primary completion2025-01-31actual

Study completion2025-01-31actual

Results first posted2025-05-14actual

Last update posted2025-05-23actual

Assets

Drug assets

Simufilam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events

Time frame:Baseline to 52 weeks

event count, event

Primary/registry result

Number of Participants With Adverse Events

Time frame:Baseline to 52 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Simufilam 100mgNumber of subjects with mild AEsn=1079 Participants	299	-
Number of subjects with moderate AEsn=1079 Participants	198	-
Number of subjects with severe AEsn=1079 Participants	63	-
Number of subjects with no AEsn=1079 Participants	519	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.