Open-label Extension for Phase 3 Clinical Trials of Simufilam
- Registration Number
- NCT05575076
- Lead Sponsor
- Cassava Sciences, Inc.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1081
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Simufilam 100 mg Simufilam simufilam 100 mg oral tablet, twice daily
- Primary Outcome Measures
Name Time Method Adverse Event Monitoring Baseline to 52 weeks To evaluate the long-term safety and tolerability of simufilam 100 mg tablets in subjects who have completed one of the two double-blind simufilam phase 3 studies.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (131)
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
MDFirst Research
🇺🇸Chandler, Arizona, United States
CCT Research - Gilbert Neurology Partners
🇺🇸Gilbert, Arizona, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
North County Neurology Associates
🇺🇸Carlsbad, California, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Sun Valley Research Center, Inc.
🇺🇸Imperial, California, United States
Senior Clinical Trials
🇺🇸Laguna Hills, California, United States
Shankle Clinic and Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Pacific Research Network, LLC
🇺🇸San Diego, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Mountain Neurological Research Center
🇺🇸Basalt, Colorado, United States
Colorado Neurological Research Center, PC
🇺🇸Denver, Colorado, United States
Ki Health Partners, LLC
🇺🇸Stamford, Connecticut, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
K2 Medical Research- Ocoee
🇺🇸Clermont, Florida, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
Artemis Institute for Clinical Research
🇺🇸Riverside, California, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, 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
CNS Healthcare - Jacksonville
🇺🇸Jacksonville, Florida, United States
Charter Research
🇺🇸Winter Park, Florida, United States
ClinCloud
🇺🇸Maitland, Florida, United States
Merritt Island Medical Research, LLC
🇺🇸Merritt Island, Florida, United States
South Florida Research Phase I-IV INC
🇺🇸Miami Springs, Florida, United States
Central Miami Medical Institute (GMI)
🇺🇸Miami, Florida, United States
Mind Institute at Miami Jewish Health
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Brainstorm Research
🇺🇸Miami, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Health Synergy Clinical Research
🇺🇸Okeechobee, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Orlando, Florida, United States
Medical Research
🇺🇸Port Orange, Florida, United States
Intercoastal Medical Group - Sarasota
🇺🇸Sarasota, Florida, United States
Alzheimer's Research & Treatment Center
🇺🇸Wellington, Florida, United States
Clinical Research of Brandon, LLC (Tampa)
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Premier Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Columbus Memory Center, PC
🇺🇸Columbus, Georgia, United States
Accel Research Sites - NeuroStudies
🇺🇸Decatur, Georgia, United States
Velocity Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Advocate Aurora Health - Advocate Memory Center
🇺🇸Park Ridge, Illinois, United States
Ascension Via Christi Research
🇺🇸Wichita, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Neuro Medical Clinic of Central Louisiana, LLC
🇺🇸Alexandria, Louisiana, United States
Neurology Center of New England
🇺🇸Foxboro, Massachusetts, United States
ActivMed Practices & Research, LLC
🇺🇸Methuen, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Boston Neuro Research Center
🇺🇸North Dartmouth, Massachusetts, United States
Headlands Eastern MA LLC
🇺🇸Plymouth, Massachusetts, United States
MedVadis Research
🇺🇸Waltham, Massachusetts, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
CCT Research - Papillion Research Center
🇺🇸Papillion, Nebraska, United States
Patient First MD
🇺🇸Middletown, New Jersey, United States
Advanced Clinical Institute, Inc
🇺🇸Neptune, New Jersey, United States
Global Medical Institutes, LLC
🇺🇸Princeton, New Jersey, United States
The Cognitive and Research Center of New Jersey (CRCNJ)
🇺🇸Springfield, New Jersey, United States
Advanced Memory Research Institute of NJ
🇺🇸Toms River, New Jersey, United States
Neurology Specialists of Monmouth County
🇺🇸West Long Branch, New Jersey, United States
Albuquerque Neuroscience, Inc
🇺🇸Albuquerque, New Mexico, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Integrative Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
SPRI Clinical Trials Brooklyn
🇺🇸Brooklyn, New York, United States
Velocity Clinical Research, Formerly Clarity Clinical Research
🇺🇸East Syracuse, New York, United States
Parker Jewish Institute for Health Care & Rehabilitation
🇺🇸New Hyde Park, New York, United States
Mid Hudson Medical Research
🇺🇸New Windsor, New York, United States
NY Neurology Associates
🇺🇸New York, New York, United States
University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
🇺🇸Rochester, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Triad Clinical Trials, LLC
🇺🇸Greensboro, North Carolina, United States
Alzheimer's Memory Center
🇺🇸Matthew, North Carolina, United States
Accellacare Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Insight Clinical Trials LLC
🇺🇸Beachwood, Ohio, United States
NeuroScience Research Center, LLC
🇺🇸Canton, Ohio, United States
Dayton Center for Neurological Disorders
🇺🇸Centerville, Ohio, United States
the Ohio State University
🇺🇸Columbus, Ohio, United States
Neurology Diagnostics
🇺🇸Dayton, Ohio, United States
Neuro-Behavioral Clinical Research
🇺🇸North Canton, Ohio, United States
Summit Research Network, LLC
🇺🇸Portland, Oregon, United States
Center for Cognitive Health - Portland
🇺🇸Portland, Oregon, United States
Keystone Clinical Studies, LLC
🇺🇸Plymouth Meeting, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Senior Adults Specialty Research, Inc
🇺🇸Austin, Texas, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Mt. Olympus Medical Research, LLC
🇺🇸Katy, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Re:Cognition Health
🇺🇸Fairfax, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Memory and Brain Wellness Center at Harborview
🇺🇸Seattle, Washington, United States
KaRa Institute of Neurological Diseases Pty. Ltd.
🇦🇺Macquarie Park, New South Wales, Australia
The University of Queensland
🇦🇺Herston, Queensland, Australia
Delmont Consulting Suites
🇦🇺Glen Iris, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Eastern Health
🇦🇺Melbourne, Victoria, Australia
Alzheimer's Research Australia
🇦🇺Nedlands, Western Australia, Australia
OCT Research ULC DBA Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
True North Clinical Research - Halifax/Nova Scotia
🇨🇦Halifax, Nova Scotia, Canada
True North Clinical Research - New Minas
🇨🇦New Minas, Nova Scotia, Canada
Dr. George Dumont University Hospital Centre
🇨🇦Moncton, New Brunswick, Canada
St. Joseph's Health Care London
🇨🇦London, Ontario, Canada
Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
🇨🇦Peterborough, Ontario, Canada
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
The Centre for Memory and Aging
🇨🇦Toronto, Ontario, Canada
Q & T Research
🇨🇦Sherbrooke, Quebec, Canada
Diex Research - Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Alpha Recherche Clinique
🇨🇦Québec, Canada
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Buk-gu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Dong-gu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Namyangju, Incheon, Korea, Republic of
Inha Unviersity Medical Center
🇰🇷Incheon, Jung-gu, Korea, Republic of
Santa Cruz Behavioral PSC
🇵🇷Bayamón, Puerto Rico
Inspira Clinical Research
🇵🇷San Juan, Puerto Rico
Barbara Diaz Hernandez Md Research, Inc.
🇵🇷San Juan, Puerto Rico