Characteristics of Treatment Responders to Galantamine

Study Overview
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Brief Summary
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To investigate the characteristics of treatment responders to galantamine.

Detailed Description
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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.

Official Title
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Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease

Conditions
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Dementia

Intervention / Treatment
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* Drug: galantamine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-responder group<br>patients who did not maintained or improved cognitive function | Drug: galantamine<br>* 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<br>* Other names: galantamine-reminyl;|
| Experimental: responder group<br>patients who maintained or improved cognitive function | Drug: galantamine<br>* 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<br>* Other names: galantamine-reminyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K) |  | baseline, 4w, 13w, 26w, 39w, 52w | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI) |  | baseline, 4w, 13w, 26w, 39w, 52w | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Galantamine, Treatment response, Efficacy, Adverse Event