TerminatedPhase 2Results posted

Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease

An Open-Label Extension of the PTI-125-04 Study Evaluating the Safety and Long-Term Treatment of Simufilam in Mild-to-Moderate Alzheimer's Disease Patients

Lead sponsor

Cassava Sciences, Inc.

Asset

Simufilam

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥50

Primary endpoint

•Adverse Event Monitoring

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 IDNCT05352763

Org study IDPTI-125-09

Timeline

Milestones

Study first posted2022-04-29actual

Study start2022-05-12actual

Primary completion2024-12-31actual

Study completion2024-12-31actual

Last update posted2025-08-15actual

Results first posted2025-08-15actual

Assets

Drug assets

Simufilam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

1. Must have completed the PTI-125-04 study or Week 96 in the PTI-125-09 study.

2. Male subjects must be willing to continue use of contraception during the study. With female partners of childbearing potential, male subjects, regardless of their fertility status, must agree to either remain abstinent or use condoms in combination with one additional highly effective method of contraception (e.g., oral or implanted contraceptives, or intrauterine devices) or an effective method of contraception (e.g., diaphragms with spermicide or cervical sponges) during the study and for 14 days after study drug dosing has been completed.

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

Adverse Event Monitoring

Time frame:Baseline to 96 Weeks

event count, event

Primary/registry result

Adverse Event Monitoring

Time frame:Baseline to 96 Weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Simufilam 100 mgn=90 Participants	90	-

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.