A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Public ClinicalTrials.gov record NCT07688213. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07688213
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 28, 2026 (Actual)
- Primary completion
- Jul 31, 2029 (Estimated)
- Completion
- Jul 31, 2029 (Estimated)
- Last update posted
- Oct 23, 2026
2026 – 2029
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Healthy Brain Clinic- Site Number : 8400011 | Long Beach | California | 90804 | Recruiting |
| Oakland Clinical- Site Number : 8400010 | Oakland | California | 94609 | Recruiting |
| Aqualane Clinical Research- Site Number : 8400001 | Naples | Florida | 34105 | Recruiting |
| K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008 | Orlando | Florida | 32751 | Recruiting |
| Charter Research - Lady Lake- Site Number : 8400004 | The Villages | Florida | 32162 | Recruiting |
| Boston Center for Memory - Newton- Site Number : 8400007 | Newton | Massachusetts | 02459 | Recruiting |
| The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005 | Springfield | New Jersey | 07081 | Recruiting |
| Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002 | Portland | Oregon | 97210 | Recruiting |
| Flourish Research - Keystone Clinical Studies- Site Number : 8400003 | Plymouth Meeting | Pennsylvania | 19462 | Recruiting |
| Kerwin Medical Center- Site Number : 8400006 | Dallas | Texas | 75231 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07688213, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07688213 live on ClinicalTrials.gov.