A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
SAR448851: Pharmaceutical form: Capsule Route of administration: Oral
Placebo: Pharmaceutical form: Capsule Route of administration: Oral
Study summary
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.
Eligibility
Primary outcome measure(s)
- Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217 — From baseline to Week 48
- Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS — From Week 48 to Week 96
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), including amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) by brain magnetic resonance imaging (MRI), laboratory assessments, vital sign measurements, electrocardiograms (ECGs) and the Columbia-Suicide Severity Rating Scale (C-SSRS)
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Oakland Clinical- Site Number : 8400010 | Oakland | California | Recruiting |
| Aqualane Clinical Research- Site Number : 8400001 | Naples | Florida | Recruiting |
| Charter Research - Lady Lake- Site Number : 8400004 | The Villages | Florida | Recruiting |
| Boston Center for Memory - Newton- Site Number : 8400007 | Newton | Massachusetts | Recruiting |
| The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005 | Springfield | New Jersey | Recruiting |
| Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002 | Portland | Oregon | Recruiting |
| Flourish Research - Keystone Clinical Studies- Site Number : 8400003 | Plymouth Meeting | Pennsylvania | Recruiting |
| Kerwin Medical Center- Site Number : 8400006 | Dallas | Texas | Recruiting |
| Investigational Site Number : 0360001 | Macquarie Park | New South Wales | Recruiting |
| Investigational Site Number : 0360004 | Melbourne | Victoria | Recruiting |
| Investigational Site Number : 3920001 | Kurashiki | Okayama-ken | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07688213 on ClinicalTrials.gov ↗ ← All trials in the UK