Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480870
Status:
COMPLETED
Last Update Posted:
2007-12-04
First Post:
2007-05-30
Brief Title:
The Effect of Anticholinesterase Drugs on Sleep in Alzheimers Disease Patients
Sponsor:
Associacao Fundo de Incentivo a Psicofarmcologia
Organization:
Associacao Fundo de Incentivo a Psicofarmcologia
Study Overview
Official Title:
The Effect of Anticholinesterase Drugs on Sleep in Alzheimers Disease Patients
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACHALZSLEEP
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None