Clinical trial NCT05575076: Open-label Extension for Phase 3 Clinical Trials of Simufilam
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Cassava Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 1081
Sex: ALL
Minimum age (years): 51
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label extension
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MDFirst Research
state: Arizona
city: Gilbert
country: United States
facility: CCT Research - Gilbert Neurology Partners
state: Arizona
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Carlsbad
country: United States
facility: North County Neurology Associates
state: California
city: Colton
country: United States
facility: Axiom Research, LLC
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center, Inc.
state: California
city: Laguna Hills
country: United States
facility: Senior Clinical Trials
state: California
city: Newport Beach
country: United States
facility: Shankle Clinic and Hoag Memorial Hospital Presbyterian
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network, LLC
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center
state: Colorado
city: Denver
country: United States
facility: Colorado Neurological Research Center, PC
state: Colorado
city: Stamford
country: United States
facility: Ki Health Partners, LLC
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Clermont
country: United States
facility: K2 Medical Research- Ocoee
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
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: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research - Sunrise
state: Florida
city: Homestead
country: United States
facility: Luminous Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV INC
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute (GMI)
state: Florida
city: Miami
country: United States
facility: Mind Institute at Miami Jewish Health
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Brainstorm Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Okeechobee
country: United States
facility: Health Synergy Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Port Orange
country: United States
facility: Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group - Sarasota
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Research & Treatment Center
state: Florida
city: Tampa
country: United States
facility: Clinical Research of Brandon, LLC (Tampa)
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Wellington
country: United States
facility: Alzheimer's Research & Treatment Center
state: Florida
city: West Palm Beach
country: United States
facility: Premier Research Institute at Palm Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center, PC
state: Georgia
city: Decatur
country: United States
facility: Accel Research Sites - NeuroStudies
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Park Ridge
country: United States
facility: Advocate Aurora Health - Advocate Memory Center
state: Illinois
city: Wichita
country: United States
facility: Ascension Via Christi Research
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Alexandria
country: United States
facility: Neuro Medical Clinic of Central Louisiana, LLC
state: Louisiana
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, LLC
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: North Dartmouth
country: United States
facility: Boston Neuro Research Center
state: Massachusetts
city: Plymouth
country: United States
facility: Headlands Eastern MA LLC
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Papillion
country: United States
facility: CCT Research - Papillion Research Center
state: Nebraska
city: Middletown
country: United States
facility: Patient First MD
state: New Jersey
city: Neptune
country: United States
facility: Advanced Clinical Institute, Inc
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey (CRCNJ)
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany
state: New York
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials Brooklyn
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Formerly Clarity Clinical Research
state: New York
city: New Hyde Park
country: United States
facility: Parker Jewish Institute for Health Care & Rehabilitation
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: New York
country: United States
facility: NY Neurology Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Greensboro
country: United States
facility: Triad Clinical Trials, LLC
state: North Carolina
city: Matthew
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare Research of Winston-Salem
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Columbus
country: United States
facility: the Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research
state: Ohio
city: Portland
country: United States
facility: Summit Research Network, LLC
state: Oregon
city: Portland
country: United States
facility: Center for Cognitive Health - Portland
state: Oregon
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies, LLC
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research, Inc
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Katy
country: United States
facility: Mt. Olympus Medical Research, LLC
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Fairfax
country: United States
facility: Re:Cognition Health
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Memory and Brain Wellness Center at Harborview
state: Washington
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Diseases Pty. Ltd.
state: New South Wales
city: Herston
country: Australia
facility: The University of Queensland
state: Queensland
city: Glen Iris
country: Australia
facility: Delmont Consulting Suites
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Eastern Health
state: Victoria
city: Nedlands
country: Australia
facility: Alzheimer's Research Australia
state: Western Australia
city: Kelowna
country: Canada
facility: OCT Research ULC DBA Okanagan Clinical Trials
state: British Columbia
city: Moncton
country: Canada
facility: Dr. George Dumont University Hospital Centre
state: New Brunswick
city: Halifax
country: Canada
facility: True North Clinical Research - Halifax/Nova Scotia
state: Nova Scotia
city: New Minas
country: Canada
facility: True North Clinical Research - New Minas
state: Nova Scotia
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Memory and Aging
state: Ontario
city: Sherbrooke
country: Canada
facility: Q & T Research
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research - Sherbrooke
state: Quebec
city: Québec
country: Canada
facility: Alpha Recherche Clinique
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Buk-gu
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Dong-gu
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Namyangju
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: Incheon
city: Incheon
country: Korea, Republic of
facility: Inha Unviersity Medical Center
state: Jung-gu
city: Bayamón
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: San Juan
country: Puerto Rico
facility: Inspira Clinical Research
city: San Juan
country: Puerto Rico
facility: Barbara Diaz Hernandez Md Research, Inc.
Study officials:
affiliation: Cassava Sciences, Inc.
name: James Kupiec, MD
role: STUDY_DIRECTOR
References: