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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. Identifier: NCT01054976
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : December 24, 2012
Last Update Posted : December 24, 2012
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Galantamine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Galantamine 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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054976

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
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Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
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Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01054976    
Other Study ID Numbers: CR015850
GAL-KOR-21 ( Other Identifier: Janssen Korea, Ltd., Korea )
GALALZ4039 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: January 22, 2010    Key Record Dates
Results First Posted: December 24, 2012
Last Update Posted: December 24, 2012
Last Verified: November 2012
Keywords provided by Janssen Korea, Ltd., Korea:
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents