Alzheimer and Sleep - Full Text View

Purpose

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	Intervention	Phase
Alzheimer's Disease	Drug: Galantamine and Donepezil	Phase I

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Galantamine hydrobromide Galantamine Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacodynamics Study

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

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750529

Contacts


Contact: Lacarin Patrick	04.73.75.11.95	placarin@chu-clermontferran.fr

Locations


France
	CPC-CIC	Not yet recruiting
	Clermont-Ferrand, France, 63003
	Contact: Dubray Claude, Pr 04.73.17.84.10 cdubray@chu-clermontferrand.fr

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Janssen-Cilag Farmaceutica Ltda.

Investigators


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

More Information

Responsible Party:	CIC CPC ( Pr Claude Dubray )
Study ID Numbers:	CHU-0038
First Received:	September 9, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00750529
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

sleep

Alzheimer

old patients

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Galantamine

Mental Disorders

Donepezil

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Parasympathomimetics

Nootropic Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Enzyme Inhibitors

Cholinergic Agents

Pharmacologic Actions

Cholinesterase Inhibitors

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Tauopathies

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	University Hospital, Clermont-Ferrand Janssen-Cilag Farmaceutica Ltda.
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00750529