The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01054976|
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : December 24, 2012
Last Update Posted : December 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Galantamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
U.S. FDA Resources
Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.
- Change From Baseline in Simple Reaction Time [ Time Frame: Baseline, Week 12 ]The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.
- Change From Baseline in Choice Reaction Time [ Time Frame: Baseline, Week 12 ]The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, Week 12 ]The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.
- Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K) [ Time Frame: Baseline, Week 12 ]DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on "not applicable (x)" which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function
- Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL) [ Time Frame: Baseline, Week 12 ]The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054976
|Study Director:||Janssen Korea, Ltd. Clinical Trial||Janssen Korea, Ltd.|