Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing SAR448851 for Dementia, Alzheimer's Type

This is a randomly assigned, compared with a dummy treatment Phase 2 study to measure the how well it works and safety of SAR448851 in early Alzheimer's disease (AD) participants. this study wants to measure how well it works and safety with once daily oral SAR448851 compared to dummy treatment (placebo) in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.

Official registry: https://clinicaltrials.gov/study/NCT07688213 · Sanofi · enrollment listed as 160

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SAR448851, or Placebo. The registry lists allocation as randomized. This is a randomly assigned, compared with a dummy treatment Phase 2 study to measure the how well it works and safety of SAR448851 in early Alzheimer's disease (AD) participants.

They plan to enroll about 160 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease

Interventions: SAR448851, Placebo

Primary outcome (registry wording): Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217

Who it is for (from inclusion criteria)

  • Ages 55 Years to 85 Years
  • Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \[NIA-AA\] Stage 3) or mild AD dementia (NIA-AA Stage 4)
  • Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening
  • The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening

Public study contact (from the registry)

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

Contact-US@sanofi.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

32 listed

+ 18 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07688213 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07688213?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07688213?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary