A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Recruiting
Phase 2Interventional Study
Dementia, Alzheimer's TypeAlzheimer's Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for people aged 55 to 85 with mild Alzheimer's disease or mild cognitive impairment. Participants will take a daily pill and might continue in the study for up to 111 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 55 and 85 years old.
I have mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.
I have a Clinical Dementia Rating score of 0.5 to 1.0.
I have a study partner who can support me.
I have evidence of amyloid buildup in my brain.
You may not be able to join if
I have a history of significant neurological diseases.
I have more than 4 microhemorrhages in my brain.
I carry two copies of the APOE4 gene.
I am currently receiving anti-amyloid immunotherapy.
I am currently receiving anticoagulant therapies.
I have had cancer in the last 3 years, except for certain skin cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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-…
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.
Contacts
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