A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease

Study acronym: TREMHANCE
StatusRecruiting
PhasePhase 2
SponsorSanofi
Started

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Record History

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  1. Trial sites expanded: 1 → 11 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 4 of 8 entries
  2. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2026 to Jul 28, 2026
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
285 trials monitored
See 12 trials at risk
Dementia
1,982 trials monitored
See 105 trials at risk
Alzheimer's Disease
1,255 trials monitored
See 68 trials at risk
This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology. This Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily. The study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort. Up to 160 participants will be included in this study.
Trial Details
NCT Number NCT07688213
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Dementia, Alzheimer's Type, Alzheimer's Disease
Related terms Alzheimer Disease
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov