The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients - Full Text View

Sponsors and Collaborators:	Associacao Fundo de Incentivo a Psicofarmcologia Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:	NCT00480870

Purpose

The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.

Condition	Intervention	Phase
Alzheimer Disease Sleep Apnea, Obstructive	Drug: donepezil Drug: Placebo	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Sleep Apnea

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:

Polysomnography parameters: sleep structure, respiratory, limb movements [ Time Frame: onset, 3 and 6 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Brain magnetic resonance imaging [ Time Frame: onset ] [ Designated as safety issue: Yes ]
laboratory tests: hematological evaluation, creatinine, vitamin B12-folic acid, thyroid hormones, GOT, GPT, GGT, bilirubin, fasting glycemia, venereal disease research test and urine sediment [ Time Frame: onset ] [ Designated as safety issue: Yes ]
electroencephalogram [ Time Frame: onset ] [ Designated as safety issue: Yes ]
Mini-mental state examination [ Time Frame: onset ] [ Designated as safety issue: Yes ]
IDATE [ Time Frame: onset ] [ Designated as safety issue: Yes ]
Frequency bands of scalp EEG areas: overall (average of all electrodes), frontal (F3, F4, F7, F8, Fz), temporal (T3, T4, T5, T6), parietal (P3, P4, Pz), central (C3, C4, Cz), and occipital (O1, O2, Oz). [ Time Frame: onset, 3 and 6 months of treatment ] [ Designated as safety issue: Yes ]
ADAS-cog scores [ Time Frame: onset, 3 and 6 months of treatment ] [ Designated as safety issue: Yes ]
Clinical Dementia Rating [ Time Frame: onset ] [ Designated as safety issue: Yes ]
EEG slowing ratio [ Time Frame: onset, 3 and 6 monthes of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	65
Study Start Date:	April 1999
Study Completion Date:	January 2005

Arms	Assigned Interventions
A: Experimental Donepezil treated Alzheimer patients	Drug: donepezil donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
B: Placebo Comparator Placebo treated Alzheimer patients	Drug: Placebo Placebo 1p / day for 1 month and 2 / day for 5 months on

Detailed Description:

Central acting cholinesterase inhibitors are the first primary pharmacological treatment approved for Alzheimer disease, of which donepezil is the most frequently used. Multicenter studies have found little toxicity, and its side effects (diarrhea, nausea, vomiting, nightmares, among others) are mild and transient. According to the literature, cholinergic active drugs may be expected to affect REM (rapid eye movement) sleep. Another possible effect is related to respiratory parameters in patients with Alzheimer disease and obstructive sleep apnea. In fact, cholinergic activity influences the upper airway opening via central and peripheral mechanisms. Intervention: Patients will be administered donepezil or placebo. The study has a randomized, double-blind placebo-controlled design. Complete polysomnography with REM sleep EEG spectral analysis and ADAS-cog scoring will be performed at baseline and after 3 and 6 months.

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Alzheimer's disease based on the probability criteria of the Alzheimer's Disease and Related Disorders Association
Rated 1 and 2 (mild to moderate level) on the Brazilian version of the Clinical Dementia Rating

Exclusion Criteria:

Other causes of dementia
Other severe medical or psychiatric disease
Clinical indication of psychoactive drugs other than experimental drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480870

Locations

Brazil
Instituto do Sono
Sao Paulo, Brazil, 04020-060

Sponsors and Collaborators

Associacao Fundo de Incentivo a Psicofarmcologia

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Principal Investigator:

Walter AS Moraes, MD PhD

Associação Fundo de Incentivo a Psicofarmacologia - AFIP

More Information

Publications:

Moraes Wdos S, Poyares DR, Guilleminault C, Ramos LR, Bertolucci PH, Tufik S. The effect of donepezil on sleep and REM sleep EEG in patients with Alzheimer disease: a double-blind placebo-controlled study. Sleep. 2006 Feb 1;29(2):199-205.

Rosa A, Poyares D, Moraes W, Cintra F. Methodology in clinical sleep research. Cell Mol Life Sci. 2007 May;64(10):1244-53.

Lucchesi LM, Pradella-Hallinan M, Lucchesi M, Moraes WA. [Sleep in psychiatric disorders] Rev Bras Psiquiatr. 2005 May;27 Suppl 1:27-32. Epub 2005 Jul 28. Review. Portuguese.

Responsible Party:	AFIP ( Walter Andre dos Santos Moraes/ MD PhD )
Study ID Numbers:	CEP nº051/99
Study First Received:	May 30, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00480870 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Alzheimer
polysomnography
REM sleep

donepezil
sleep apnea
oxygen saturation

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Alzheimer Disease
Respiration Disorders
Dyssomnias
Sleep Disorders
Central Nervous System Diseases
Cholinergic Agents

Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Sleep Disorders, Intrinsic
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Respiratory Tract Diseases
Mental Disorders
Donepezil
Dementia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sleep Apnea, Obstructive
Physiological Effects of Drugs
Sleep Disorders
Neurodegenerative Diseases
Brain Diseases
Cholinergic Agents
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Mental Disorders
Therapeutic Uses
Donepezil
Dementia

Nootropic Agents
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Dyssomnias
Enzyme Inhibitors
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009