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The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01054976
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : December 24, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date  ICMJE January 21, 2010
First Posted Date  ICMJE January 22, 2010
Results First Submitted Date  ICMJE May 4, 2012
Results First Posted Date  ICMJE December 24, 2012
Last Update Posted Date December 24, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
The change in computerized attention test score from baseline at 12 weeks. [ Time Frame: At week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • The improvement in Alzheimer's Disease Assessment Scale - cognitive subscale 11 (ADAS-cog11) [ Time Frame: 12 weeks ]
  • Seoul- Instrumental Activities of daily livings (S-IADL) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Official Title  ICMJE The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Brief Summary This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.
Detailed Description This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Galantamine
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.
Study Arms  ICMJE Experimental: Galantamine
Intervention: Drug: Galantamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
99
Original Actual Enrollment  ICMJE
 (submitted: January 21, 2010)
94
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
  • K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
  • Reliable Guardian available to the patients
  • Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion Criteria:

  • Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
  • Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
  • Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
  • brain tumor, nerve syphilis, meningitis, encephalitis
  • epilepsy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054976
Other Study ID Numbers  ICMJE CR015850
GAL-KOR-21 ( Other Identifier: Janssen Korea, Ltd., Korea )
GALALZ4039 ( Other Identifier: Janssen Korea, Ltd., Korea )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Korea, Ltd., Korea
Study Sponsor  ICMJE Janssen Korea, Ltd., Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
PRS Account Janssen Korea, Ltd., Korea
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP