A daily pill test of SAR448851 for early Alzheimer’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, double-blind study with an optional open-label extension. It compares daily oral SAR448851 to placebo in adults aged 55 to 85 with mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia and evidence of brain amyloid. The trial has two parts: Part A assesses efficacy and safety over up to 96 weeks, followed by Part B where participants may continue; an optional dose 2 cohort will evaluate a different SAR448851 dose. Up to 160 participants are planned across sites in California and Florida. The sponsor is Sanofi, with clinical sites at Long Beach, Oakland, and Naples.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.
* 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.
* Have a study partner who must provide separate written informed consent at screening. Study partner should be \>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.
* The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.

Exclusion Criteria:

* The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).
* The participant has evidence of more than 4 microhemorrhages (\<10 mm in diameter) or superficial siderosis.
* The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).
* The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.
* The participant is currently receiving anticoagulant therapies.
* The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it's running

• Healthy Brain Clinic- Site Number : 8400011
  Long Beach, California, United States Recruiting
• Oakland Clinical- Site Number : 8400010
  Oakland, California, United States Recruiting
• Aqualane Clinical Research- Site Number : 8400001
  Naples, Florida, United States Recruiting
• K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008
  Orlando, Florida, United States Recruiting
• Alzheimer's Research and Treatment Center - Stuart, FL- Site Number : 8400014
  Stuart, Florida, United States Recruiting
• Axiom Brain Health- Site Number : 8400019
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.