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

NCT05352763 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-15

Study results available
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Summary

This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, and C-SSRS.

Conditions

Interventions

DRUG

simufilam

simufilam 100 mg oral tablet, twice daily

Sponsors & Collaborators

  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Cook, JD · Chief Operating and Legal Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352763 on ClinicalTrials.gov