Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196690
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Donepezil in Chronic Poststroke Aphasia a Randomized Controlled Trial
Sponsor:
Gabinete Berthier y MartÃnez
Organization:
Gabinete Berthier y MartÃnez
Study Overview
Official Title:
Treatment With Donepezil of Chronic Aphasia and Sensorimotor Deficits Associated to Cerebrovascular Accidents a Double-BlindPlacebo-Controlled Randomized Parallel Trial
Status:
COMPLETED
Status Verified Date:
2005-09
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:
None
Brief Summary:
Aphasia impairment of language function due to brain damagemay be treated with speech-language therapy and drugs Several drugs have been studied but with limited success
Recent data suggest that the neurotransmitter acetylcholine may be reduced in brain damaged subjects and that drugs that stimulates acetylcholine activity may help recovery of aphasic deficits particularly when paired with speech-language therapy
Recent evidence indicates that medicaments acting on the neurotransmitter acetylcholine may promote improvement of aphasic deficits and our previous open-label study of donepezil in post-stroke aphasia showed benefits in all patients and observed benefit were long-lasting 6 monthsThis study will test the safety and efficacy of donepezil an agent acting on acetylcholinein subjects with stroke-related chronic aphasia more than 1 yr of evolution
Recent data suggest that the neurotransmitter acetylcholine may be reduced in brain damaged subjects and that drugs that stimulates acetylcholine activity may help recovery of aphasic deficits particularly when paired with speech-language therapy
Recent evidence indicates that medicaments acting on the neurotransmitter acetylcholine may promote improvement of aphasic deficits and our previous open-label study of donepezil in post-stroke aphasia showed benefits in all patients and observed benefit were long-lasting 6 monthsThis study will test the safety and efficacy of donepezil an agent acting on acetylcholinein subjects with stroke-related chronic aphasia more than 1 yr of evolution
Detailed Description:
Prior clinical information of donepezil treatment of post-stroke aphasia comes from single-case studies small case-series and an open-label study In addition an extension phase of a small open-label study also suggest that the efficacy of donepezil in chronic post-stroke apahsia is maintained at long-term follow-up These data collectively suggest that in post-stroke donepezil is effective and well-tolerated with a limited potential for causing clinically significant interactions when prescribed with other medications However these results are preliminary and should be judged parsimoniously until randomized controlled trials will be performedMoreover recent data by our group also showed that donepezil may improve sensorimotor deficits hemiparesisin some patients
The use of acetylcholinesterase inhibitors such as donepezil in post-stroke may be justified because in vivo and postmortem studies have shown that patients with vascular dementia and lesions in subcortical and cortical structures have deficient cholinergic neurotransmission that results from interruption of cholinergic pathways linking the basal forebrain with the cerebral cortex including the perisylvian language areaIn addition two large-scale randomized controlled trials in patients pure vascular dementia and vascular cognitive impairment found that donepezil was significantly superior to placebo on cognition global function and activities of daily livingAnd the most noticeable benefits of donepezil over placebo at doses of 5-mg and 10-mg were found on the Alzheimers Disease Assessment Scale-cognitive subscale ADAS-Cog11 an assessment instrument highly reliant upon language variables 6 out of 11 items
We evaluated the efficacy of donepezil in patients with chronic aphasia associated with strokeThis is a 20-week randomized placebo-controlled double-blind parallel study that enrolled aphasic patient with more than one year of evolution During the study all patients continued receiving two hours weekly of conventional speech-language therapy Patients were randomized in an 11 ratio to donepezil 5-mgday for the first 4 weeks followed by forced dose escalation to 10-mgday thereafter n 13 or placebo n 13 and then a 4 week washout period The primary efficacy measures were the Aphasia Quotient AQ of the Western Aphasia Battery and the Communicative Activity Log Secondary efficacy measures included selected subtests of the Psycholinguistic Assessment of Language Processing in Aphasia that examined phonological and lexical-semantic domains and the Stroke Aphasia Depression Questionnaire
The use of acetylcholinesterase inhibitors such as donepezil in post-stroke may be justified because in vivo and postmortem studies have shown that patients with vascular dementia and lesions in subcortical and cortical structures have deficient cholinergic neurotransmission that results from interruption of cholinergic pathways linking the basal forebrain with the cerebral cortex including the perisylvian language areaIn addition two large-scale randomized controlled trials in patients pure vascular dementia and vascular cognitive impairment found that donepezil was significantly superior to placebo on cognition global function and activities of daily livingAnd the most noticeable benefits of donepezil over placebo at doses of 5-mg and 10-mg were found on the Alzheimers Disease Assessment Scale-cognitive subscale ADAS-Cog11 an assessment instrument highly reliant upon language variables 6 out of 11 items
We evaluated the efficacy of donepezil in patients with chronic aphasia associated with strokeThis is a 20-week randomized placebo-controlled double-blind parallel study that enrolled aphasic patient with more than one year of evolution During the study all patients continued receiving two hours weekly of conventional speech-language therapy Patients were randomized in an 11 ratio to donepezil 5-mgday for the first 4 weeks followed by forced dose escalation to 10-mgday thereafter n 13 or placebo n 13 and then a 4 week washout period The primary efficacy measures were the Aphasia Quotient AQ of the Western Aphasia Battery and the Communicative Activity Log Secondary efficacy measures included selected subtests of the Psycholinguistic Assessment of Language Processing in Aphasia that examined phonological and lexical-semantic domains and the Stroke Aphasia Depression Questionnaire
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