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

Conditions

• Alzheimer's Disease
• Dementia, Alzheimer's Type

Eligibility Criteria

Sex

ALL

Age

55 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• SAR448851 — DRUG
  Pharmaceutical form: Capsule Route of administration: Oral
• Placebo — DRUG
  Pharmaceutical form: Capsule Route of administration: Oral

Study Details

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.

Key Dates

First listed

Jul 7, 2026

Start date

Jul 28, 2026

Status verified

Aug 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SAR448851
  Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
• Placebo Comparator: Placebo
  Participants will receive placebo oral daily for 48 weeks

Primary Outcome Measure

Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217 [ Time Frame: From baseline to Week 48 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (1)

Find similar trials in The Villages, FL

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