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Completed

NCT Number: NCT00480870

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

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.

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Key information

Conditions

Alzheimer Disease Apnea Brain Diseases Central Nervous System Diseases Dementia Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto do Sono

São Paulo, 04020-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Polysomnography parameters: sleep structure, respiratory, limb movements

    Time frame: onset, 3 and 6 months of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Associacao Fundo de Incentivo a Psicofarmcologia

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: ACHALZSLEEP

Important dates

Study start
1999
Study completion
2005
First posted
May 31, 2007
Registry last updated
Dec 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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