Alzheimer and Sleep

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT00750529

Collaborator

Janssen-Cilag Farmaceutica Ltda. (Industry)

Enrollment

Locations

Arm

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Galantamine and Donepezil	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Galantamine	Drug: Galantamine and Donepezil the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication

Arm

Intervention/Treatment

Experimental: Galantamine

Drug: Galantamine and Donepezil

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

Outcome Measures

Primary Outcome Measures

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

Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep [during the iatrogenic modifications]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003
2	CPC-CIC	Clermont-Ferrand		France	63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand
Janssen-Cilag Farmaceutica Ltda.

Investigators

Principal Investigator: Dubray Claude, Pr, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT00750529

Other Study ID Numbers:

CHU-0038

First Posted:

Sep 10, 2008

Last Update Posted:

Jul 8, 2014

Last Verified:

Jul 1, 2014

Keywords provided by University Hospital, Clermont-Ferrand

sleep

Alzheimer

old patients

Additional relevant MeSH terms:

Alzheimer Disease

Donepezil

Galantamine

Study Results

No Results Posted as of Jul 8, 2014