Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2007-04-30
2009-10-31
Brief Summary
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Detailed Description
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1. to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
2. to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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non-responder group
patients who did not maintained or improved cognitive function
galantamine
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
responder group
patients who maintained or improved cognitive function
galantamine
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
Interventions
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galantamine
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.
ALL
No
Sponsors
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Janssen Korea, Ltd., Korea
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Doh Kwan Kim
Principal Investigator
Principal Investigators
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Doh Kwan Kim, PhD, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2007-04-021
Identifier Type: -
Identifier Source: org_study_id
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