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

NCT ID: NCT05352763

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2024-12-31

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.

Detailed Description

This is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the Phase 2 study, PTI-125-04. All subjects will provide consent to enroll into this study. Simufilam will be administered as coated oral tablets. The last study visit, Month 24, from the PTI-125-04 study will be used for the Study Day 1 visit assessments in this extension study. Clinic visits will occur every 12 weeks ±10 days. A complete physical examination will be performed at Study Day 1, Week 48 and Week 96. Subjects will return to the clinic every 12 weeks for safety assessments of vital signs, AE monitoring, C-SSRS, and drug dispensation and accountability. Blood draws for clinical laboratory testing, urine collection for urinalysis, and ECGs will be performed at Study Day 1 and Weeks 24, 48, 72, and 96. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simufilam 100 mg

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

Group Type: EXPERIMENTAL

simufilam

Intervention Type: DRUG

simufilam 100 mg oral tablet, twice daily

Interventions

simufilam

simufilam 100 mg oral tablet, twice daily

Intervention Type: DRUG

Other Intervention Names

PTI-125

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cassava Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Cook, JD

Role: STUDY_CHAIR

Chief Operating and Legal Officer

Locations

Cognitive Clinical Trials

Gilbert, Arizona, United States

Valley Research Center, Inc.

Imperial, California, United States

Brain Matters Research

Delray Beach, Florida, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

IMIC Research

Palmetto Bay, Florida, United States

Cognitive Clinical Trials

Papillion, Nebraska, United States

Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

the Ohio State University

Columbus, Ohio, United States

Senior Adults Specialty Research

Austin, Texas, United States

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

Ottawa, Ontario, Canada

Toronto Memory Program ULC

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PTI-125-09

Identifier Type: -

Identifier Source: org_study_id