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

Alzheimer Disease Clinical Trial

— ACHALZSLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480870
• Other study ID #: CEP nº051/99
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2007
• Last updated: December 3, 2007
• Start date: April 1999
• Est. completion date: January 2005

Study information

• Verified date: December 2007
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep Apnea, Obstructive

Intervention

Drug:
• donepezil
donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
• Placebo
Placebo 1p / day for 1 month and 2 / day for 5 months on

Locations

Country	Name	City	State
Brazil	Instituto do Sono	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Lucchesi LM, Pradella-Hallinan M, Lucchesi M, Moraes WA. [Sleep in psychiatric disorders]. Rev Bras Psiquiatr. 2005 May;27 Suppl 1:27-32. Epub 2005 Jul 28. Review. Portuguese. — View Citation

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. — View Citation

Rosa A, Poyares D, Moraes W, Cintra F. Methodology in clinical sleep research. Cell Mol Life Sci. 2007 May;64(10):1244-53. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography parameters: sleep structure, respiratory, limb movements		onset, 3 and 6 months of treatment	Yes
Secondary	Brain magnetic resonance imaging		onset	Yes
Secondary	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	Yes
Secondary	electroencephalogram		onset	Yes
Secondary	Mini-mental state examination		onset	Yes
Secondary	IDATE		onset	Yes
Secondary	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).		onset, 3 and 6 months of treatment	Yes
Secondary	ADAS-cog scores		onset, 3 and 6 months of treatment	Yes
Secondary	Clinical Dementia Rating		onset	Yes
Secondary	EEG slowing ratio		onset, 3 and 6 monthes of treatment	Yes