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

NCT05352763 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: PTI-125-09
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 11

Brief 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

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Event Monitoring

  Number of Participants with Adverse Events

  Baseline to 96 Weeks

Study Arms (1)

Simufilam 100 mg

EXPERIMENTAL

simufilam 100 mg oral tablets, b.i.d.

Drug: simufilam

Interventions

simufilam DRUG

simufilam 100 mg oral tablet, twice daily

Also known as: PTI-125

Simufilam 100 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cassava Sciences, Inc.: lead

Study Sites (11)

Cognitive Clinical Trials

Gilbert, Arizona, 85296, United States

Location

Valley Research Center, Inc.

Imperial, California, 92251, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

IMIC Research

Palmetto Bay, Florida, 33157, United States

Location

Cognitive Clinical Trials

Papillion, Nebraska, 68046, United States

Location

Advanced Memory Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

the Ohio State University

Columbus, Ohio, 43221, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

Ottawa, Ontario, K1Z1G3, Canada

Location

Toronto Memory Program ULC

Toronto, Ontario, M3B 2S7, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Simufilam

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Project Manager
• Organization: Cassava Sciences

closedstudyinfo@cassavasciences.com

5125013180

Study Officials

• Chris Cook, JD

  Chief Operating and Legal Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label extension study

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 29, 2022
• Study Start: May 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-07

Locations

US (9); CA (2)