A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01734395|
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Galantamine||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1882 participants|
|Official Title:||An Observational, Multi-Center Study to Demonstrate That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease|
|Study Start Date :||March 2007|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
U.S. FDA Resources
Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).
This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.
- Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) [ Time Frame: Baseline (Week 1 [Day 1]), Week 16 ]AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.
- Change From Baseline at Week 16 in Burden Interview (BI) Scores [ Time Frame: Baseline, Week 16 ]BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.
- Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) [ Time Frame: Baseline, Week 16 ]MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734395
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|