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The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

NCT ID: NCT00480870

Last Updated: 2007-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer Disease Sleep Apnea, Obstructive

Keywords

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Alzheimer polysomnography REM sleep donepezil sleep apnea oxygen saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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A

Donepezil treated Alzheimer patients

Group Type EXPERIMENTAL

donepezil

Intervention Type DRUG

donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.

B

Placebo treated Alzheimer patients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1p / day for 1 month and 2 / day for 5 months on

Interventions

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donepezil

donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.

Intervention Type DRUG

Placebo

Placebo 1p / day for 1 month and 2 / day for 5 months on

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role lead

Responsible Party

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AFIP

Principal Investigators

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Walter AS Moraes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Associação Fundo de Incentivo a Psicofarmacologia - AFIP

Locations

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Instituto do Sono

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Rosa A, Poyares D, Moraes W, Cintra F. Methodology in clinical sleep research. Cell Mol Life Sci. 2007 May;64(10):1244-53. doi: 10.1007/s00018-007-6535-y.

Reference Type BACKGROUND
PMID: 17364137 (View on PubMed)

Lucchesi LM, Pradella-Hallinan M, Lucchesi M, Moraes WA. [Sleep in psychiatric disorders]. Braz J Psychiatry. 2005 May;27 Suppl 1:27-32. doi: 10.1590/s1516-44462005000500006. Epub 2005 Jul 28. Portuguese.

Reference Type BACKGROUND
PMID: 16082452 (View on PubMed)

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;29(2):199-205. doi: 10.1093/sleep/29.2.199.

Reference Type RESULT
PMID: 16494088 (View on PubMed)

McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

Reference Type DERIVED
PMID: 33189083 (View on PubMed)

Moraes W, Poyares D, Sukys-Claudino L, Guilleminault C, Tufik S. Donepezil improves obstructive sleep apnea in Alzheimer disease: a double-blind, placebo-controlled study. Chest. 2008 Mar;133(3):677-83. doi: 10.1378/chest.07-1446. Epub 2008 Jan 15.

Reference Type DERIVED
PMID: 18198262 (View on PubMed)

Other Identifiers

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CEP nº051/99

Identifier Type: -

Identifier Source: org_study_id