Could a daily pill slow Alzheimer's? new trial tests SAR448851
NCT ID NCT07688213
First seen Jul 07, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether an oral drug called SAR448851 can slow the progression of early Alzheimer's disease. It includes people with mild cognitive impairment or mild dementia due to Alzheimer's, who have brain amyloid plaques. Participants receive either the drug or a placebo daily for 48 weeks, with an optional longer-term follow-up. The study measures changes in blood markers of brain damage, brain scans, and thinking abilities.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SAR448851 (oral capsule)
- What this could lead to
- If successful, this could point toward a daily pill that slows memory loss and brain damage in early Alzheimer's disease.
- What could go wrong
- This is an early-phase trial with only 160 participants. The drug may not improve symptoms or could cause side effects like brain swelling or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Charter Research - Lady Lake- Site Number : 8400004
RECRUITINGThe Villages, Florida, 32162, United States
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Other studies related to the condition(s) this trial covers.
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