Trial studying safety and effects for Dementia, Alzheimer's Type
Official title A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT07688213
What this study is testing
What is SAR448851?
SAR448851 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for dementia, alzheimer's type.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- 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)...
- 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...
- The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at...
You likely can't join if
- The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Naples, Florida, United States
- The Villages, Florida, United States
- Newton, Massachusetts, United States
- Springfield, New Jersey, United States
- Portland, Oregon, United States
- Plymouth Meeting, Pennsylvania, United States
- Dallas, Texas, United States
- Macquarie Park, New South Wales, Australia
- Melbourne, Victoria, Australia
- Kurashiki, Okayama-ken, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Naples, Florida, United States; The Villages, Florida, United States; Newton, Massachusetts, United States; Springfield, New Jersey, United States; Portland, Oregon, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.