NCT00530478

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of donepezil on the recovery of cognitive function in patients with stroke and to delineate the neurophysiologic mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using functional neuroimaging technique.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
Last Updated

September 17, 2007

Status Verified

July 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 13, 2007

Conditions

Stroke

Keywords

DonepezilStrokeCognitive functionCognitive neural network

Interventions

DonepezilDRUG

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke in the territory of right or left middle cerebral artery
  • Post-onset duration of the recent-onset stroke is over 3 months
  • Cognitive deficit ranged from 10 to 26 by minimal mental status examination (MMSE) score
  • Disturbance in activities of daily living (ADL) ranged 0.5 \~ 2.0 by clinical dementia rating (CDR) scale

You may not qualify if:

  • Severe internal carotid artery stenosis on the lesion side
  • Cardiac pacemaker or intracranial metal insertion
  • Post-stroke seizure disorder or any evidence of epileptic spikes on electroencephalography (EEG)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Suk Hoon Ohn, MD, MS

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Yun Hee Park, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Hee Kim, MD, PHD

CONTACT

82-2-3410-2818yunkim@smc.samsung.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Last Updated

September 17, 2007

Record last verified: 2007-07

Locations

KR(1)