Effect of Donepezil on the Reorganization of Cognitive Ne... | NCT00530478

Studies
Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment

NCT00530478

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Sep 17, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Stroke

Interventions

Donepezil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2007

First Submission Date that Met QC Criteria

Sep 13, 2007

First Posted Date

Sep 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2007

Last Update Posted Date

Sep 17, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Donepezil	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yun-Hee Kim, MD, PHD	Contact	82-2-3410-2818		yunkim@smc.samsung.co.kr

Overall Officials

Name	Affiliation	Role
Suk Hoon Ohn, MD, MS	Samsung Medical Center	Principal Investigator
Yun Hee Park, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Seoul	135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077265	Donepezil

Ancestor Terms

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided