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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT00480870
First received: May 30, 2007
Last updated: December 3, 2007
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

Resource links provided by NLM:


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
Experimental: A
Donepezil treated Alzheimer patients
Drug: donepezil
donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
Placebo Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Walter Andre dos Santos Moraes/ MD PhD, AFIP
ClinicalTrials.gov Identifier: NCT00480870     History of Changes
Other Study ID Numbers: CEP nº051/99
Study First Received: May 30, 2007
Last Updated: December 3, 2007
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

Additional relevant MeSH terms:
Alzheimer Disease
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Cholinesterase Inhibitors
Donepezil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014