The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type

NCT00216515 | Completed Phase 4

• 1 other identifier: CR005047
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; galantamine; attention; executive function

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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)

Interventions

galantamine hydrobromide DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2004
• Study Completion: November 1, 2005
• Last Updated: January 24, 2011

Record last verified: 2011-01