Siponimod for Early Alzheimer's Disease
This study is testing if Siponimod, a drug already approved for multiple sclerosis, can help people with early Alzheimer's disease. Researchers believe Siponimod might slow down brain shrinkage (atrophy) in people with mild Alzheimer's disease or mild cognitive impairment (MCI) who are at higher risk for Alzheimer's. You could be eligible if you are between 50 and 84 years old. The main goal is to see if Siponimod is safe and well-tolerated. The study is also looking at how much brain atrophy occurs over time. The current status of this study is unclear.
- Study design
- This is a Phase II, double-blind (meaning neither you nor your doctor will know if you're getting the drug or placebo), randomized study with 105 participants. You would receive either Siponimod or a placebo (an inactive substance that looks like Siponimod) for 12 months, followed by a 6-month break.
- What's involved
- You would take Siponimod or placebo once daily for 12 months. You would have volumetric MRI (vMRI) scans at the beginning, at 6 months, 12 months, and 18 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Repurposing Siponimod for Alzheimer's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Marwan N Sabbagh, MD · PRINCIPAL_INVESTIGATOR · St. Josep's Hospital and Medical Center, Phoenix
- Boris Decourt, PhD · STUDY_CHAIR · Texas Tech University Health Sciences Center
Who to contact
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What this trial measures
- Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)18 months
To evaluate the safety and tolerability of Siponimod titrated for up to 12 months and washed out for 6 months in mild AD subjects. (Subjects will receive gradual titration regimen of Siponimod starting at 0.25mg/day and increasing every two weeks by 0.25 mg, up to final dosage of 1 mg/day.) Safety will be assessed at each study visit through completion of comprehensive tests and procedures aimed at monitoring for potentials adverse events (AEs). Study staff will also gather direct reports from subjects regarding any adverse events.