drugset / Trial / NCT01266525
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-01
- Completion
- 2013-01
Publications
- McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
- Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAR110894 | Unknown | 0.5 mg | Oral |
| Subject | SAR110894 | Unknown | 2 mg | Oral |
| Subject | SAR110894 | Unknown | 5 mg | Oral |
| Background | Donepezil | Small molecule | 5 mg | — |
| Background | Donepezil | Small molecule | 10 mg | — |