A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01734395
First received: November 22, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.


Condition Intervention Phase
Alzheimer's Disease
Drug: Galantamine
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational, Multi-Center Study to Demonstrate That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Attention Questionnaire at Week 16 [ Time Frame: Week 1 (baseline), Week 16 ] [ Designated as safety issue: No ]
    Attention questionnaire evaluates the attention of patients with dementia and is designed for their caregivers to evaluate the patients' attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap.


Secondary Outcome Measures:
  • Change from baseline in Burden interview (BI) at Week 16 [ Time Frame: Week 1 (baseline), Week 16 ] [ Designated as safety issue: No ]
    BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden).

  • Change from screening in Mini Mental State Exam (MMSE) at Week 16 [ Time Frame: Week -2 (screening), Week 1 (baseline), Week 16 ] [ Designated as safety issue: No ]
    MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment.

  • Change from baseline in Clinical Dementia Rating Scale (CDR) at Week 16 [ Time Frame: Week 1 (baseline), Week 16 ] [ Designated as safety issue: No ]
    CDR is a 5-point scale to evaluates the clinical patterns and severity of the patients suspected or diagnosed as dementia in 6 areas: memory, orientation, judgment and problem solving ability, social activity, domestic living and hobbies, and hygiene and dressing up, where 0 = no cognitive impairment, 0.5 = very mild dementia, 1 = mild, 2 = moderate, and 3 = severe.

  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Week -2 (screening), Week 1 (baseline), Week 16 ] [ Designated as safety issue: Yes ]

Enrollment: 1882
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Galantamine
Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).
Drug: Galantamine
This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.
Other Names:
  • Razadyne
  • Reminyl

Detailed Description:

This is an open-label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multi-center (study conducted at multiple sites) study. The study mainly consists of 2 phases including, the screening phase (14 days before administration of study medication) and treatment phase (16 weeks). In the treatment phase, patients will receive galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg (if tolerable). Safety evaluations will include assessment of adverse events. The total duration of the study will be 18 weeks.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Alzheimer's disease

Criteria

Inclusion Criteria:

  • Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
  • Measuring standard: K-MMSE is 10 to 24
  • Patient with reliable Guardian

Exclusion Criteria:

  • Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy
  • Major psychiatric patients such as major depression and schizophrenia
  • Patients with treatment-resistant gastric and peptic ulcer
  • Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734395

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01734395     History of Changes
Other Study ID Numbers: CR100958, GAL-KOR-024, GALALZ4045
Study First Received: November 22, 2012
Last Updated: February 12, 2013
Health Authority: Korean: Korean Food & Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Alzheimer's disease
Caregiver's Burden in Alzheimer's disease
Galantamine
Razadyne
Reminyl

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013