Dementia Alzheimer's Type Clinical Trial
Official title:
A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy
Primary Objective:
- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in
comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's
disease (AD) while on stable donepezil therapy
Secondary Objectives:
- To explore the effect of SAR110894 on functional impairment, global clinical status and
behavioral disturbances;
- To assess the safety/tolerability of SAR110894;
- To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
- To explore caregiver time consumption and distress changes.
The total study duration for each patient is approximatively 36 - 38 weeks broken down as
follows:
- Screening period: up to 4 weeks,
- Treatment period: 24 weeks,
- Follow-up period: 10 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02667496 -
Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
|
Phase 2 |