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Clinical trial

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

ID
Name
PTI-125-09
Description
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.
Trial arms
Trial start
2022-05-12
Estimated PCD
2025-10-29
Trial end
2025-11-29
Status
Active (not recruiting)
Phase
Early phase I
Treatment
simufilam
simufilam 100 mg oral tablets
Arms:
Simufilam 100 mg
Size
90
Primary endpoint
Adverse Event Monitoring
Baseline to 96 Weeks
Eligibility criteria
• Subjects must have completed the PTI-125-04 study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label extension study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-01-08

1 organization

1 product

1 indication

Product
simufilam
Indication
Alzheimer's Disease
Organization
Cassava Sciences