The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients (ACHALZSLEEP)
This study has been completed.
Sponsor:
Associacao Fundo de Incentivo a Psicofarmcologia
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
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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
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 May 19, 2013