StrokeNCT00530478
Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment
A study testing Donepezil in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Donepezil
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 135-710
Yun-Hee Kim, MD, PHD, 82-2-3410-2818, yunkim@smc.samsung.co.kr
About this study
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.
- Conditions
- Stroke
- Being tested
- Donepezil
- Keywords
- Donepezil, Stroke, Cognitive function, Cognitive neural network
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Suk Hoon Ohn, MD, MS, Principal investigator, Samsung Medical CenterYun Hee Park, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530478
- Sponsor's protocol ID
- 2006-04-023
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00530478
- Acronym / sponsor ID
- 2006-04-023
- Conditions
- Stroke
- Keywords
- Donepezil, Stroke, Cognitive function, Cognitive neural network
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk Hoon Ohn, MD, MS principal investigator
Samsung Medical Center
Yun Hee Park, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-Hee Kim, MD, PHD (82-2-3410-2818, yunkim@smc.samsung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2007.