Open-label Extension for Phase 3 Clinical Trials of Simufilam

Alzheimer Disease Clinical Trial

Official title:

An Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Simufilam 100 mg Tablets in Participants With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05575076
• Other study ID #: PTI-125-10
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: November 7, 2022
• Est. completion date: July 15, 2026

Study information

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

Clinical Trial Summary

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

Description:

This is a multi-national, multi-center, fixed-dose, 52-week, open-label extension study. After completing participation in either RETHINK-ALZ (PTI-125-06) or REFOCUS-ALZ (PTI-125-07), subjects will have the option to participate in this study. After the subject provides consent and the Investigator confirms the subject satisfies both inclusion and exclusion criteria, the study drug will be administered at the research site on Study Day 1 and subsequent visits will be scheduled.

We anticipate up to 1600 subjects may enroll in this study. Approximately up to 150 clinical sites in the USA, Canada, South Korea, and Australia will have the option to participate in this collaborative research effort.

For subjects electing to participate, the clinical and laboratory assessments from the Week 76 (REFOCUS-ALZ) or Week 52 (RETHINK-ALZ) End-of-Treatment visit will serve as Baseline Visit assessments for the open-label study on Study Day 1. All subjects will return in 4 weeks and every 12 weeks thereafter for safety assessments. At all post-baseline visits, subjects will report any adverse events since their last visit. In addition to adverse event monitoring, safety will be evaluated at every visit by vital signs, brief examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis) and the Columbia Suicide Severity Rating Scale (C-SSRS). Study drug use since the last visit will be assessed and a new bottle of study drug will be dispensed.

The emerging subject safety assessments will be monitored throughout the study by an independent Data Safety Monitoring Board (DSMB).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1600
• Est. completion date: July 15, 2026
• Est. primary completion date: July 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 89 Years

Eligibility

Inclusion Criterion:

• Completed RETHINK-ALZ (PTI-125-07) or REFOCUS-ALZ (PTI-125-06).

• Clinical presentation continues to be consistent with Alzheimer's disease.

• Availability of a study partner.

Exclusion Criteria:

• Residence in a skilled nursing facility requiring 24-hour care.

• Evidence of a neurologic condition other than AD that significantly contributes to the subject's dementia.

• Current clinically significant psychiatric diagnosis other than AD.

• Unstable, clinically significant medical condition other than AD.

• Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Simufilam
simufilam 100 mg oral tablet, twice daily

Locations

Country	Name	City	State
Canada	Kawartha Centre - Redefining Healthy Aging	Peterborough	Ontario
Canada	Alpha Recherche Clinique	Québec
Canada	Q & T Research	Sherbrooke	Quebec
Canada	Toronto Memory Program	Toronto	Ontario
Puerto Rico	Santa Cruz Behavioral PSC	Bayamón
United States	Neurological Associates of Albany	Albany	New York
United States	Albuquerque Neuroscience, Inc	Albuquerque	New Mexico
United States	Neuro Medical Clinic of Central Louisiana, LLC	Alexandria	Louisiana
United States	Dent Neurologic Institute	Amherst	New York
United States	Advanced Research Center, Inc.	Anaheim	California
United States	JEM Research Institute	Atlantis	Florida
United States	Senior Adults Specialty Research, Inc	Austin	Texas
United States	Mountain Neurological Research Center	Basalt	Colorado
United States	Insight Clinical Trials LLC	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	Clinical Research of Brandon, LLC	Brandon	Florida
United States	SPRI Clinical Trials Brooklyn	Brooklyn	New York
United States	NeuroScience Research Center, LLC	Canton	Ohio
United States	North County Neurology Associates	Carlsbad	California
United States	Dayton Center for Neurological Disorders	Centerville	Ohio
United States	MDFirst Research	Chandler	Arizona
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Axiom Research, LLC	Colton	California
United States	Columbus Memory Center, PC	Columbus	Georgia
United States	the Ohio State University	Columbus	Ohio
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Texas Neurology, PA	Dallas	Texas
United States	Neurology Diagnostics	Dayton	Ohio
United States	Arrow Clinical Trials	Daytona Beach	Florida
United States	Accel Research Sites - NeuroStudies	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Colorado Neurological Research Center, PC	Denver	Colorado
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Velocity Clinical Research, Formerly Clarity Clinical Research	East Syracuse	New York
United States	Re:Cognition Health	Fairfax	Virginia
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Neuro-Pain Medical Center	Fresno	California
United States	Neurology Center of North Orange County	Fullerton	California
United States	CCT Research - Gilbert Neurology Partners	Gilbert	Arizona
United States	Triad Clinical Trials, LLC	Greensboro	North Carolina
United States	Velocity Clinical Research, Hallandale Beach	Hallandale Beach	Florida
United States	Galiz Research	Hialeah	Florida
United States	Infinity Clinical Research - Sunrise	Hollywood	Florida
United States	Luminous Clinical Research	Homestead	Florida
United States	Sun Valley Research Center, Inc.	Imperial	California
United States	CNS Healthcare - Jacksonville	Jacksonville	Florida
United States	Mt. Olympus Medical Research, LLC	Katy	Texas
United States	Charter Research	Lady Lake	Florida
United States	Senior Clinical Trials	Laguna Hills	California
United States	ClinCloud	Maitland	Florida
United States	Alzheimer's Memory Center	Matthew	North Carolina
United States	ActivMed Practices & Research, LLC	Methuen	Massachusetts
United States	Central Miami Medical Institute (GMI)	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	South Florida Research Phase I-IV INC	Miami Springs	Florida
United States	Patient First MD	Middletown	New Jersey
United States	Advanced Clinical Institute, Inc	Neptune	New Jersey
United States	Parker Jewish Institute for Health Care & Rehabilitation	New Hyde Park	New York
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Mid Hudson Medical Research	New Windsor	New York
United States	NY Neurology Associates	New York	New York
United States	Shankle Clinic and Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Boston Neuro Research Center	North Dartmouth	Massachusetts
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	CCT Research - Papillion Research Center	Papillion	Nebraska
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Xenoscience, Inc.	Phoenix	Arizona
United States	Keystone Clinical Studies, LLC	Plymouth Meeting	Pennsylvania
United States	Medical Research	Port Orange	Florida
United States	Center for Cognitive Health - Portland	Portland	Oregon
United States	Summit Research Network, LLC	Portland	Oregon
United States	Global Medical Institutes, LLC	Princeton	New Jersey
United States	Artemis Institute for Clinical Research	Riverside	California
United States	University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program	Rochester	New York
United States	Pacific Research Network, LLC	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Intercoastal Medical Group - Sarasota	Sarasota	Florida
United States	Memory and Brain Wellness Center at Harborview	Seattle	Washington
United States	The Cognitive and Research Center of New Jersey (CRCNJ)	Springfield	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Alzheimer's Research & Treatment Center	Stuart	Florida
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Clinical Research of Brandon, LLC (Tampa)	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Advanced Memory Research Institute of NJ	Toms River	New Jersey
United States	Alzheimer's Research & Treatment Center	Wellington	Florida
United States	Neurology Specialists of Monmouth County	West Long Branch	New Jersey
United States	Premier Research Institute at Palm Beach Neurology	West Palm Beach	Florida
United States	Ascension Via Christi Research	Wichita	Kansas
United States	Grayline Research Center	Wichita Falls	Texas
United States	Accellacare Research of Winston-Salem	Winston-Salem	North Carolina
United States	Charter Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cassava Sciences, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event monitoring	Adverse event monitoring	Baseline to 52 weeks