Back to resultsCharacteristics of Treatment Responders to Galantamine
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
galantamine
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Alzheimer's disease, Galantamine, Treatment response, Efficacy, Adverse Event
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
non-responder group
responder group
Arm Description
patients who did not maintained or improved cognitive function
patients who maintained or improved cognitive function
Outcomes
Primary Outcome Measures
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
Secondary Outcome Measures
Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
Full Information
NCT ID
NCT01029132
First Posted
December 6, 2009
Last Updated
January 4, 2016
Sponsor
Samsung Medical Center
Collaborators
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT01029132
Brief Title
Characteristics of Treatment Responders to Galantamine
Official Title
Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the characteristics of treatment responders to galantamine.
Detailed Description
The purposes of this study are:
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.
to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Alzheimer's disease, Galantamine, Treatment response, Efficacy, Adverse Event
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-responder group
Arm Type
Experimental
Arm Description
patients who did not maintained or improved cognitive function
Arm Title
responder group
Arm Type
Experimental
Arm Description
patients who maintained or improved cognitive function
Intervention Type
Drug
Intervention Name(s)
galantamine
Other Intervention Name(s)
galantamine-reminyl
Intervention Description
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
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
Time Frame
baseline, 4w, 13w, 26w, 39w, 52w
Secondary Outcome Measure Information:
Title
Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
Time Frame
baseline, 4w, 13w, 26w, 39w, 52w
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
Korean version Mini-Mental State Examination scores between 10 and 26
History of cognitive decline that had been gradual in onset and progressive over at least 6 months
A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
Cerebral injuries induced by trauma, hypoxia, and/or ischemia
Clinically active cerebrovascular disease; History of seizure disorder
Other physical conditions that required acute treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doh Kwan Kim, PhD, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Characteristics of Treatment Responders to Galantamine
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