The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type - Full Text View

Sponsor:	Janssen Korea, Ltd., Korea
Information provided by:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00216515

Purpose

The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine.

Condition	Intervention	Phase
Alzheimer Disease	Drug: galantamine hydrobromide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Prospective, Open-Labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Galantamine hydrobromide Galantamine

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test

Secondary Outcome Measures:

Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)

Estimated Enrollment:	106
Study Start Date:	March 2004
Estimated Study Completion Date:	November 2005

Detailed Description:

Recent studies suggest that an attention deficit occurs at early stage of Alzheimer's disease and affects patients' activities of daily living. In other words, some patients without language or visuospatial dysfunction have severe impairment of activities of daily living, which might result from attention deficit. Another recent clinical study showed that galantamine is more effective in attention and vigilance of Alzheimer's disease patients than donepezil. The study hypothesis is that galantamine will improve attention and frontal executive function in Alzheimer's disease patients and is well-tolerated.

8 mg/day for the first 4 weeks, 16 mg for the next 8 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients aged 50 years or older
Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16
Measuring standard MMSE-K 10 to 26
Patients who are literate
Dementia patients being nursed by the family
Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective)

Exclusion Criteria:

If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial
Neurodegenerative diseases (e.g. 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, brain tumor
Amentia
Epilepsy
Major psychiatric patients such as major depression and schizophrenia
Treatment-resistant gastric and peptic ulcer
Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease(thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
Patients complaining of severe difficulty in urination
Patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve
Patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial
Patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial)
Patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor
Patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216515

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:

Janssen Korea, Ltd. Clinical Trial

Janssen Korea, Ltd., Korea

More Information

No publications provided

Study ID Numbers:	CR005047
Study First Received:	September 13, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00216515 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

attention
executive function
Alzheimer's disease
galantamine

Additional relevant MeSH terms:

Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Galantamine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010