Alzheimer and Sleep

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750529
• Other study ID #: CHU-0038
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2008
• Last updated: July 4, 2014
• Start date: November 2008
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CPC-CIC	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Janssen-Cilag Farmaceutica Ltda.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep		during the iatrogenic modifications	Yes