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Donepezil in Chronic Poststroke Aphasia: a Randomized Controlled Trial

NCT00196690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2005-09-20

No results posted yet for this study

Summary

* Aphasia (impairment of language function due to brain damage)may 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 months).This study will test the safety and efficacy of donepezil (an agent acting on acetylcholine)in subjects with stroke-related chronic aphasia (more than 1 yr of evolution).

Conditions

Interventions

DRUG

Donepezil

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Gabinete Berthier y Martínez

    lead OTHER

Principal Investigators

  • Marcelo L. Berthier, M.D., Ph.D. · Gabinete Berthier y Martínez. Malaga, Spain. Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga, Malaga, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2005-03-31

Countries

  • Spain

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196690 on ClinicalTrials.gov