NCT00480870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 alzheimer-disease

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_4 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
Last Updated

December 4, 2007

Status Verified

December 1, 2007

First QC Date

May 30, 2007

Last Update Submit

December 3, 2007

Conditions

Alzheimer DiseaseSleep Apnea, Obstructive

Keywords

AlzheimerpolysomnographyREM sleepdonepezilsleep apneaoxygen saturation

Outcome Measures

Primary Outcomes (1)

  • Polysomnography parameters: sleep structure, respiratory, limb movements

    onset, 3 and 6 months of treatment

Secondary Outcomes (9)

  • Brain magnetic resonance imaging

    onset

  • laboratory tests: hematological evaluation, creatinine, vitamin B12-folic acid, thyroid hormones, GOT, GPT, GGT, bilirubin, fasting glycemia, venereal disease research test and urine sediment

    onset

  • electroencephalogram

    onset

  • Mini-mental state examination

    onset

  • IDATE

    onset

  • +4 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Donepezil treated Alzheimer patients

Drug: donepezil

B

PLACEBO COMPARATOR

Placebo treated Alzheimer patients

Drug: Placebo

Interventions

donepezilDRUG

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

A
PlaceboDRUG

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

B

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono

São Paulo, São Paulo, 04020-060, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 17364137BACKGROUND

  • 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.

    PMID: 16082452BACKGROUND

  • 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.

    PMID: 16494088RESULT

  • 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.

    PMID: 33189083DERIVED

  • 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.

    PMID: 18198262DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseSleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Walter AS Moraes, MD PhD

    Associação Fundo de Incentivo a Psicofarmacologia - AFIP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

April 1, 1999

Study Completion

January 1, 2005

Last Updated

December 4, 2007

Record last verified: 2007-12

Locations

BR(1)