In short
SAR448851 is an investigational oral substance being studied for early Alzheimer's disease. It is currently in a Phase 2 clinical trial that plans to enroll 1,066 participants. The trial is authorised and will measure changes in a blood marker of Alzheimer's disease as well as long-term safety.
SAR448851 is an investigational substance being studied for early Alzheimer's disease. It is given orally, and the trial includes a 25 mg dose. The trial also uses MK-6240, a radioactive tracer given by intravenous bolus, to help measure the effect of SAR448851.
Key points
- SAR448851 is an investigational substance with no marketing authorisation in these records.
- It is being studied in a Phase 2 trial for early Alzheimer's disease.
- The trial plans to enroll 1,066 participants and is currently authorised.
- SAR448851 is given as an oral medication, with a 25 mg dose reported in the trial.
- The trial measures plasma p-tau217, a blood biomarker of Alzheimer's disease, and long-term safety.
What is SAR448851?
SAR448851 is an investigational substance, meaning it is not yet authorised as a medicine. It is being developed as an oral treatment for early Alzheimer's disease. The trial record lists it as a drug given by mouth, with a 25 mg dose reported. No trade name or other development code appears in the data.
How does SAR448851 work?
The trial does not state the mechanism of action of SAR448851. What the trial does show is that researchers are measuring plasma p-tau217, a fluid biomarker of Alzheimer's disease, to evaluate the effect of SAR448851 compared with placebo. Plasma p-tau217 is a protein fragment found in the blood that is associated with Alzheimer's disease changes in the brain.
Which conditions is SAR448851 used or studied for?
- Dementia Alzheimer's type — the trial studies SAR448851 in participants with early Alzheimer's disease, which is a progressive condition affecting memory and thinking.
How is SAR448851 given?
SAR448851 is given orally, as a drug taken by mouth. The trial reports a 25 mg dose. A matched placebo for SAR448851 is also used in the trial for comparison.
What do the clinical trials show?
There is one clinical trial of SAR448851 in the data. It is a Phase 2 interventional study in participants with early Alzheimer's disease. The trial is authorised, meaning it has received approval to proceed, and plans to enroll 1,066 participants.
The trial has two parts. Part A, including an optional dose 2 cohort, evaluates the effect of SAR448851 versus placebo on plasma p-tau217 from baseline to Week 48. Part B evaluates the long-term safety and tolerability of SAR448851 from Week 48 to Week 96, by counting the number of participants experiencing at least one treatment-emergent adverse event (TEAE).
The interventions include SAR448851 at 25 mg orally, a matched placebo, and MK-6240, a radioactive tracer given by intravenous bolus at 185 MBq.