SIPO1-AD
SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients with Mild Alzheimer’s Disease Dementia
Purpose
The primary objectives are to evaluate the safety and tolerability of the drug in subjects with mild Alzheimer’s disease dementia, as assessed through regular clinical evaluations throughout the dosing period. Critically, eventual treatment-emergent toxicities will drive our decision process to pursue or stop dosing. The secondary objective is to determine drug effect on relative annual brain atrophy rates in the two groups by comparing pre- and post-exposure volumetric MRI data. Tertiary objectives will be evaluated through the utilization of cognitive assessments throughout study,
Who can participate
You may qualify for this study if:
- Male or female at least 50 years of age, but less than 85 (84 attime of screening)
- Must have a diagnosis of mild Alzheimer’s Dementia determined by medical record review.
- Vision and hearing must be sufficient to comply with study procedures. Be able to take oral medications.
- Must be able to attend all study visits indicated in the schedule of visits.
- Must have a collateral informant/study partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits/interviews.
- Documented Mini Mental State Exam (MMSE) score between 21-26 at Screening Visit.
- CT or MRI scan of the brain within 12 months of enrollment showing no evidence of significant focal lesions or other pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.
Visits
The trial will last 4-5 years.