Alzheimer and Sleep

This study is currently recruiting participants.
Verified September 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Janssen-Cilag Farmaceutica Ltda.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00750529
First received: September 9, 2008
Last updated: September 2, 2013
Last verified: September 2013

September 9, 2008
September 2, 2013
November 2008
May 2014   (final data collection date for primary outcome measure)
Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil [ Time Frame: administration of galantamine or donépézil ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00750529 on ClinicalTrials.gov Archive Site
Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep [ Time Frame: during the iatrogenic modifications ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Alzheimer and Sleep
Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
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
Experimental: Galantamine
Intervention: Drug: Galantamine and Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Lacarin Patrick 04.73.75.11.95 placarin@chu-clermontferran.fr
France
 
NCT00750529
CHU-0038
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Janssen-Cilag Farmaceutica Ltda.
Principal Investigator: Dubray Claude, Pr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP