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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480870
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : December 4, 2007
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Sleep Apnea, Obstructive Drug: donepezil Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
Study Start Date : April 1999
Actual Study Completion Date : January 2005

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Polysomnography parameters: sleep structure, respiratory, limb movements [ Time Frame: onset, 3 and 6 months of treatment ]

Secondary Outcome Measures :
  1. Brain magnetic resonance imaging [ Time Frame: onset ]
  2. 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 ]
  3. electroencephalogram [ Time Frame: onset ]
  4. Mini-mental state examination [ Time Frame: onset ]
  5. IDATE [ Time Frame: onset ]
  6. 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 ]
  7. ADAS-cog scores [ Time Frame: onset, 3 and 6 months of treatment ]
  8. Clinical Dementia Rating [ Time Frame: onset ]
  9. EEG slowing ratio [ Time Frame: onset, 3 and 6 monthes of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480870

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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
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Principal Investigator: Walter AS Moraes, MD PhD Associação Fundo de Incentivo a Psicofarmacologia - AFIP
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Walter Andre dos Santos Moraes/ MD PhD, AFIP Identifier: NCT00480870    
Other Study ID Numbers: CEP nº051/99
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: December 4, 2007
Last Verified: December 2007
Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
REM sleep
sleep apnea
oxygen saturation
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents