Alzheimer and Sleep

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Galantamine and Donepezil

• Registration Number: NCT00750529
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

Detailed Description

Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

Study Timeline

• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Study Start: 2008-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 65 and over years old
• Patients suffering from Alzheimer disease
• Patient living with someone at home
• Written consent given

Exclusion Criteria

• Galantamine or Donepezil hypersensibility
• Patient living alone and in a medicalized structure
• Concomitant medication
• Chronical diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Galantamine	Galantamine and Donepezil	-

Primary Outcome Measures

Name	Time	Method
Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil	administration of galantamine or donépézil

Secondary Outcome Measures

Name	Time	Method
Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep	during the iatrogenic modifications

Trial Locations

Locations (2)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CPC-CIC; 🇫🇷 Clermont-Ferrand, France