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Open-label Extension for Phase 3 Clinical Trials of Simufilam
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
1 other identifier
interventional
1,081
5 countries
134
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Nov 2022
Shorter than P25 for phase_3 alzheimer-disease
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedResults Posted
Study results publicly available
May 14, 2025
CompletedMay 23, 2025
February 1, 2025
2.2 years
October 7, 2022
April 28, 2025
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
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.
Baseline to 52 weeks
Study Arms (1)
Simufilam 100 mg
EXPERIMENTALsimufilam 100 mg oral tablet, twice daily
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
MDFirst Research
Chandler, Arizona, 85286, United States
CCT Research - Gilbert Neurology Partners
Gilbert, Arizona, 85297, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
North County Neurology Associates
Carlsbad, California, 92011, United States
Axiom Research, LLC
Colton, California, 92324, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Sun Valley Research Center, Inc.
Imperial, California, 92251, United States
Senior Clinical Trials
Laguna Hills, California, 92653, United States
Shankle Clinic and Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Pacific Research Network, LLC
San Diego, California, 92103, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Mountain Neurological Research Center
Basalt, Colorado, 81621, United States
Colorado Neurological Research Center, PC
Denver, Colorado, 80210, United States
Ki Health Partners, LLC
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
K2 Medical Research- Ocoee
Clermont, Florida, 34711, United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Galiz Research
Hialeah, Florida, 33016, United States
Infinity Clinical Research - Sunrise
Hollywood, Florida, 33024, United States
Luminous Clinical Research
Homestead, Florida, 33030, United States
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256, United States
Charter Research
Lady Lake, Florida, 32792, United States
ClinCloud
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Central Miami Medical Institute (GMI)
Miami, Florida, 33125, United States
Mind Institute at Miami Jewish Health
Miami, Florida, 33137, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Brainstorm Research
Miami, Florida, 33176, United States
South Florida Research Phase I-IV INC
Miami Springs, Florida, 33166, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Health Synergy Clinical Research
Okeechobee, Florida, 34972, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32801, United States
Medical Research
Port Orange, Florida, 32127, United States
Intercoastal Medical Group - Sarasota
Sarasota, Florida, 34239, United States
Alzheimer's Research & Treatment Center
Stuart, Florida, 34997, United States
Clinical Research of Brandon, LLC (Tampa)
Tampa, Florida, 33603, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Alzheimer's Research & Treatment Center
Wellington, Florida, 33414, United States
Premier Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Charter Research
Winter Park, Florida, 32792, United States
Columbus Memory Center, PC
Columbus, Georgia, 31909, United States
Accel Research Sites - NeuroStudies
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Advocate Aurora Health - Advocate Memory Center
Park Ridge, Illinois, 60068, United States
Ascension Via Christi Research
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40504, United States
Neuro Medical Clinic of Central Louisiana, LLC
Alexandria, Louisiana, 71301, United States
Neurology Center of New England
Foxborough, Massachusetts, 02035, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Boston Neuro Research Center
North Dartmouth, Massachusetts, 02747, United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360, United States
MedVadis Research
Waltham, Massachusetts, 02451, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
CCT Research - Papillion Research Center
Papillion, Nebraska, 68046, United States
Patient First MD
Middletown, New Jersey, 07748, United States
Advanced Clinical Institute, Inc
Neptune City, New Jersey, 07753, United States
Global Medical Institutes, LLC
Princeton, New Jersey, 08540, United States
The Cognitive and Research Center of New Jersey (CRCNJ)
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764, United States
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109, United States
Albany Medical Center
Albany, New York, 12208, United States
Neurological Associates of Albany
Albany, New York, 12208, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
SPRI Clinical Trials Brooklyn
Brooklyn, New York, 11235, United States
Velocity Clinical Research, Formerly Clarity Clinical Research
East Syracuse, New York, 13057, United States
Parker Jewish Institute for Health Care & Rehabilitation
New Hyde Park, New York, 11040-1433, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
NY Neurology Associates
New York, New York, 10003, United States
University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
Rochester, New York, 14620, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Triad Clinical Trials, LLC
Greensboro, North Carolina, 27410, United States
Alzheimer's Memory Center
Matthew, North Carolina, 28105, United States
Accellacare Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Insight Clinical Trials LLC
Beachwood, Ohio, 44122, United States
NeuroScience Research Center, LLC
Canton, Ohio, 44718, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
the Ohio State University
Columbus, Ohio, 43221, United States
Neurology Diagnostics
Dayton, Ohio, 45459, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720, United States
Summit Research Network, LLC
Portland, Oregon, 97210, United States
Center for Cognitive Health - Portland
Portland, Oregon, 97225, United States
Keystone Clinical Studies, LLC
Plymouth Meeting, Pennsylvania, 19462, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Senior Adults Specialty Research, Inc
Austin, Texas, 78757, United States
Texas Neurology, PA
Dallas, Texas, 75206, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75231, United States
Mt. Olympus Medical Research, LLC
Katy, Texas, 77450, United States
Grayline Research Center
Wichita Falls, Texas, 76309, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Memory and Brain Wellness Center at Harborview
Seattle, Washington, 98104, United States
KaRa Institute of Neurological Diseases Pty. Ltd.
Macquarie Park, New South Wales, 2113, Australia
The University of Queensland
Herston, Queensland, 4029, Australia
Delmont Consulting Suites
Glen Iris, Victoria, 3146, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Eastern Health
Melbourne, Victoria, 3128, Australia
Alzheimer's Research Australia
Nedlands, Western Australia, 6009, Australia
OCT Research ULC DBA Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
Dr. George Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3, Canada
True North Clinical Research - Halifax/Nova Scotia
Halifax, Nova Scotia, B3S 1N2, Canada
True North Clinical Research - New Minas
New Minas, Nova Scotia, B4N 3R7, Canada
St. Joseph's Health Care London
London, Ontario, N6C 5J1, Canada
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H2P4, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
The Centre for Memory and Aging
Toronto, Ontario, M4G 3E8, Canada
Q & T Research
Sherbrooke, Quebec, J1J 2G2, Canada
Diex Research - Sherbrooke
Sherbrooke, Quebec, J1L 0H8, Canada
Alpha Recherche Clinique
Québec, G3K 2P8, Canada
Barbara Diaz Hernandez Md Research, Inc.
San Juan, PR, 00926, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, 00961, Puerto Rico
Inspira Clinical Research
San Juan, 00918, Puerto Rico
Kyungpook National University Chilgok Hospital
Daegu, Buk-gu, 41404, South Korea
Chonnam National University Hospital
Gwangju, Dong-gu, 61469, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gachon University Gil Hospital
Namyangju, Incheon, 21565, South Korea
Inha Unviersity Medical Center
Incheon, Jung-gu, 22332, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Cassava Sciences
Study Officials
- STUDY DIRECTOR
James Kupiec, MD
Cassava Sciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 12, 2022
Study Start
November 7, 2022
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
May 23, 2025
Results First Posted
May 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share