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Alzheimer and Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750529

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CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Janssen-Cilag Farmaceutica Ltda.
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Principal Investigator: Dubray Claude, Pr University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT00750529    
Other Study ID Numbers: CHU-0038
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Clermont-Ferrand:
old patients
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Autonomic Agents
Peripheral Nervous System Agents