Open-label Extension for Phase 3 Clinical Trials of Simufilam

NCT05575076
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Terminated
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Participants
1,081
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Lead sponsor
Cassava Sciences, Inc.
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Start date
2022-11-07
clinicaltrials.gov
Number of sites
134
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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.
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Short title
Open-label Extension for Phase 3 Clinical Trials of Simufilam
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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
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Control arm
Open label
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 3
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Study type
Interventional
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Reason stopped
sponsor decision
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Completion date
2025-01-31
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First posted
2022-10-12
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Registry last updated
2025-05-23
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Primary completion date
2025-01-31
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Start date
2022-11-07
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Actual participants
1,081
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Participants
1,081
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
134
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Cassava Sciences, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05575076
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ClinicalTrials.gov ID
NCT05575076
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants With Adverse Events

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
51 Years
Maximum age
89 Years
Healthy volunteers
No

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.

  • 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.
Sources for eligibility
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  • MDFirst ResearchChandler, United States
  • CCT Research - Gilbert Neurology PartnersGilbert, United States
  • Xenoscience, Inc.Phoenix, United States
  • Banner Alzheimer's InstitutePhoenix, United States
  • Banner Sun Health Research InstituteSun City, United States
  • Advanced Research Center, Inc.Anaheim, United States
  • North County Neurology AssociatesCarlsbad, United States
  • Axiom Research, LLCColton, United States
  • ATP Clinical Research, Inc.Costa Mesa, United States
  • Neuro-Pain Medical CenterFresno, United States
  • Neurology Center of North Orange CountyFullerton, United States
  • Sun Valley Research Center, Inc.Imperial, United States
  • Senior Clinical TrialsLaguna Hills, United States
  • Shankle Clinic and Hoag Memorial Hospital PresbyterianNewport Beach, United States
  • Artemis Institute for Clinical ResearchRiverside, United States
  • Pacific Research Network, LLCSan Diego, United States
  • Syrentis Clinical ResearchSanta Ana, United States
  • Mountain Neurological Research CenterBasalt, United States
  • Colorado Neurological Research Center, PCDenver, United States
  • Ki Health Partners, LLCStamford, United States
  • JEM Research InstituteAtlantis, United States
  • Neurology Offices of South FloridaBoca Raton, United States
  • K2 Medical Research- OcoeeClermont, United States
  • Arrow Clinical TrialsDaytona Beach, United States
  • Brain Matters ResearchDelray Beach, United States

And 109 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)