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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05352763
• Other study ID #: PTI-125-09
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 12, 2022
• Est. completion date: November 29, 2025

Study information

• Verified date: January 2024
• Source: Cassava Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 29, 2025
• Est. primary completion date: October 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older
• Eligibility: • Subjects must have completed the PTI-125-04 study.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• simufilam
simufilam 100 mg oral tablets

Locations

Country	Name	City	State
Canada	Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic	Ottawa	Ontario
Canada	Toronto Memory Program ULC	Toronto	Ontario
United States	Senior Adults Specialty Research	Austin	Texas
United States	the Ohio State University	Columbus	Ohio
United States	Brain Matters Research	Delray Beach	Florida
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Cognitive Clinical Trials	Gilbert	Arizona
United States	Valley Research Center, Inc.	Imperial	California
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

Sponsors (1)

Lead Sponsor	Collaborator
Cassava Sciences, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Monitoring	Adverse Event Monitoring	Baseline to 96 Weeks