Clinical trial NCT05352763: Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Cassava Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label extension study
Primary purpose: TREATMENT

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).

Eligibility criteria: • Subjects must have completed the PTI-125-04 study.

Primary outcomes:
measure: Adverse Event Monitoring
timeFrame: Baseline to 96 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Cognitive Clinical Trials
state: Arizona
city: Imperial
country: United States
facility: Valley Research Center, Inc.
state: California
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Research
state: Florida
city: Papillion
country: United States
facility: Cognitive Clinical Trials
state: Nebraska
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Columbus
country: United States
facility: the Ohio State University
state: Ohio
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program ULC
state: Ontario
Study officials:
References: