Under construction – not a live service
Sign in

NCT05575076TerminatedPhase 3

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

Source: ClinicalTrials.gov · Last updated 23 May 2025

Reason given: sponsor decision

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1081 (actual)
First submitted
7 Oct 2022
Start date
7 Nov 2022
Primary completion date
31 Jan 2025
Lead sponsor
Cassava Sciences, Inc.
NCT number
NCT05575076

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

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

Criteria the registry did not label

  • 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.

Age in the registry: 51 years to 89 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Delmont Consulting SuitesGlen IrisAustraliaUnknown status
Austin HealthHeidelbergAustraliaUnknown status
The University of QueenslandHerstonAustraliaUnknown status
KaRa Institute of Neurological Diseases Pty. Ltd.Macquarie ParkAustraliaUnknown status
Eastern HealthMelbourneAustraliaUnknown status
The Alfred HospitalMelbourneAustraliaUnknown status
Alzheimer's Research AustraliaNedlandsAustraliaUnknown status
True North Clinical Research - Halifax/Nova ScotiaHalifaxCanadaUnknown status
OCT Research ULC (dba Okanagan Clinical Trials)KelownaCanadaUnknown status
St. Joseph's Health Care LondonLondonCanadaUnknown status
Dr. George Dumont University Hospital CentreMonctonCanadaUnknown status
True North Clinical Research - New MinasNew MinasCanadaUnknown status
Ottawa Memory ClinicOttawaCanadaUnknown status
Kawartha Centre - Redefining Healthy AgingPeterboroughCanadaUnknown status
Alpha Recherche CliniqueQuébecCanadaUnknown status
Q & T ResearchSherbrookeCanadaUnknown status
Diex Research - SherbrookeSherbrookeCanadaUnknown status
The Centre for Memory and AgingTorontoCanadaUnknown status
Toronto Memory ProgramTorontoCanadaUnknown status
Kyungpook National University Chilgok HospitalDaeguSouth KoreaUnknown status
Chonnam National University HospitalGwangjuSouth KoreaUnknown status
Inha Unviersity Medical CenterIncheonSouth KoreaUnknown status
Gachon University Gil HospitalNamyangjuSouth KoreaUnknown status
Seoul National University Bundang HospitalSeongnam-siSouth KoreaUnknown status
Santa Cruz Behavioral PSCBayamónPuerto RicoUnknown status
Barbara Diaz Hernandez MD Research IncSan JuanPuerto RicoUnknown status
INSPIRA Clinical ResearchSan JuanPuerto RicoUnknown status
Albany Medical CenterAlbanyUnited StatesUnknown status
Neurological Associates of AlbanyAlbanyUnited StatesUnknown status
Albuquerque Neuroscience Inc.AlbuquerqueUnited StatesUnknown status
Neuro Medical Clinic of Central Louisiana, LLCAlexandriaUnited StatesUnknown status
Dent Neurologic InstituteAmherstUnited StatesUnknown status
Advanced Research Center, Inc.AnaheimUnited StatesUnknown status
JEM Research InstituteAtlantisUnited StatesUnknown status
Senior Adults Specialty Research, IncAustinUnited StatesUnknown status
Mountain Neurological Research CenterBasaltUnited StatesUnknown status
Insight Clinical Trials LLCBeachwoodUnited StatesUnknown status
Northwest Clinical Research CenterBellevueUnited StatesUnknown status
Neurology Offices of South FloridaBoca RatonUnited StatesUnknown status
Integrative Clinical Trials, LLCBrooklynUnited StatesUnknown status
SPRI Clinical Trials BrooklynBrooklynUnited StatesUnknown status
NeuroScience Research Center LLCCantonUnited StatesUnknown status
North County Neurology AssociatesCarlsbadUnited StatesUnknown status
Dayton Center for Neurological DisordersCentervilleUnited StatesUnknown status
MDFirst ResearchChandlerUnited StatesUnknown status
Clinical Research ProfessionalsChesterfieldUnited StatesUnknown status
K2 Medical Research- OcoeeClermontUnited StatesUnknown status
Axiom Research, LLCColtonUnited StatesUnknown status
Columbus Memory Center, PCColumbusUnited StatesUnknown status
The Ohio State UniversityColumbusUnited StatesUnknown status
ATP Clinical Research, Inc.Costa MesaUnited StatesUnknown status
Baylor Scott & White Research InstituteDallasUnited StatesUnknown status
Texas Neurology, PADallasUnited StatesUnknown status
Neurology DiagnosticsDaytonUnited StatesUnknown status
Arrow Clinical TrialsDaytona BeachUnited StatesUnknown status
Accel Research Sites-NeuroStudiesDecaturUnited StatesUnknown status
Brain Matters ResearchDelray BeachUnited StatesUnknown status
Colorado Neurological Research Center, PCDenverUnited StatesUnknown status
Rhode Island Mood & Memory Research InstituteEast ProvidenceUnited StatesUnknown status
Velocity Clinical Research, Formerly Clarity Clinical ResearchEast SyracuseUnited StatesUnknown status
Re:Cognition HealthFairfaxUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest FloridaFort MyersUnited StatesUnknown status
Neurology Center of New EnglandFoxboroughUnited StatesUnknown status
Neuro-Pain Medical CenterFresnoUnited StatesUnknown status
Neurology Center of North Orange CountyFullertonUnited StatesUnknown status
CCT Research - Gilbert Neurology PartnersGilbertUnited StatesUnknown status
Triad Clinical Trials, LLCGreensboroUnited StatesUnknown status
Velocity Clinical Research, Hallandale BeachHallandaleUnited StatesUnknown status
Galiz ResearchHialeahUnited StatesUnknown status
Infinity Clinical Research - SunriseHollywoodUnited StatesUnknown status
Luminous Clinical ResearchHomesteadUnited StatesUnknown status
Sun Valley Research Center, Inc.ImperialUnited StatesUnknown status
CNS Healthcare - JacksonvilleJacksonvilleUnited StatesUnknown status
Mt. Olympus Medical Research, LLCKatyUnited StatesUnknown status
Charter ResearchLady LakeUnited StatesUnknown status
Senior Clinical TrialsLaguna HillsUnited StatesUnknown status
University of KentuckyLexingtonUnited StatesUnknown status
ClinCloudMaitlandUnited StatesUnknown status
Alzheimer's Memory CenterMatthewUnited StatesUnknown status
Velocity Clinical Research, BoiseMeridianUnited StatesUnknown status
Merritt Island Medical Research, LLCMerritt IslandUnited StatesUnknown status
ActivMed Practices & Research, LLCMethuenUnited StatesUnknown status
New Horizon Research CenterMiamiUnited StatesUnknown status
Brainstorm ResearchMiamiUnited StatesUnknown status
Central Miami Medical Institute (GMI)MiamiUnited StatesUnknown status
Mind Institute at Miami Jewish HealthMiamiUnited StatesUnknown status
South Florida Research Phase I-IV INCMiami SpringsUnited StatesUnknown status
Patient First MDMiddletownUnited StatesUnknown status
Advanced Clinical Institute, IncNeptune CityUnited StatesUnknown status
Parker Jewish Institute for Health Care & RehabilitationNew Hyde ParkUnited StatesUnknown status
Shankle Clinic and Hoag Memorial Hospital PresbyterianNewport BeachUnited StatesUnknown status
Suncoast Clinical Research, Inc.New Port RicheyUnited StatesUnknown status
Boston Center for MemoryNewtonUnited StatesUnknown status
Mid Hudson Medical ResearchNew WindsorUnited StatesUnknown status
NY Neurology AssociatesNew YorkUnited StatesUnknown status
Neuro-Behavioral Clinical ResearchNorth CantonUnited StatesUnknown status
Boston Neuro Research CenterNorth DartmouthUnited StatesUnknown status
Renstar Medical ResearchOcalaUnited StatesUnknown status
Health Synergy Clinical ResearchOkeechobeeUnited StatesUnknown status
Clinical Neuroscience Solutions Inc. dba CNS HealthcareOrlandoUnited StatesUnknown status
CCT Research - Papillion Research CenterPapillionUnited StatesUnknown status
Advocate Aurora Health - Advocate Memory CenterPark RidgeUnited StatesUnknown status
Xenoscience Inc.PhoenixUnited StatesUnknown status
Banner Alzheimer's InstitutePhoenixUnited StatesUnknown status
Headlands Eastern MA LLCPlymouthUnited StatesUnknown status
Keystone Clinical Studies, LLCPlymouth MeetingUnited StatesUnknown status
Summit Research Network, LLCPortlandUnited StatesUnknown status
Center for Cognitive Health - PortlandPortlandUnited StatesUnknown status
Medical ResearchPort OrangeUnited StatesUnknown status
Global Medical Institutes, LLCPrincetonUnited StatesUnknown status
Artemis Institute for Clinical ResearchRiversideUnited StatesUnknown status
University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education ProgramRochesterUnited StatesUnknown status
Pacific Research Network, LLCSan DiegoUnited StatesUnknown status
Syrentis Clinical ResearchSanta AnaUnited StatesUnknown status
Intercoastal Medical Group - SarasotaSarasotaUnited StatesUnknown status
Memory and Brain Wellness Center at HarborviewSeattleUnited StatesUnknown status
The Cognitive and Research Center of New Jersey (CRCNJ)SpringfieldUnited StatesUnknown status
Ki Health Partners, LLCStamfordUnited StatesUnknown status
Richmond Behavioral AssociatesStaten IslandUnited StatesUnknown status
Alzheimer's Research & Treatment CenterStuartUnited StatesUnknown status
Palmetto Clinical ResearchSummervilleUnited StatesUnknown status
Banner Sun Health Research InstituteSun CityUnited StatesUnknown status
Clinical Research of Brandon, LLC (Tampa)TampaUnited StatesUnknown status
Stedman Clinical TrialsTampaUnited StatesUnknown status
Advanced Memory Research Institute of NJToms RiverUnited StatesUnknown status
MedVadis ResearchWalthamUnited StatesUnknown status
Alzheimer's Research & Treatment CenterWellingtonUnited StatesUnknown status
Neurology Specialists of Monmouth CountyWest Long BranchUnited StatesUnknown status
Premier Research Institute at Palm Beach NeurologyWest Palm BeachUnited StatesUnknown status
Ascension via Christi ResearchWichitaUnited StatesUnknown status
Grayline Research CenterWichita FallsUnited StatesUnknown status
Accellacare Research of Winston SalemWinston-SalemUnited StatesUnknown status
Charter ResearchWinter ParkUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.