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Alzheimer and Sleep

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ClinicalTrials.gov Identifier: NCT00750529
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : July 8, 2014
Janssen-Cilag Farmaceutica Ltda.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

September 9, 2008
September 10, 2008
July 8, 2014
November 2008
September 2013   (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 ]
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 ]
Same as current
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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.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
September 2013
September 2013   (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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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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
July 2014

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