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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Galantamine

Drug

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

Primary outcomes

Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)

Time frame: Baseline (Week 1 [Day 1]), Week 16

AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's 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. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.
Change From Baseline at Week 16 in Burden Interview (BI) Scores

Time frame: Baseline, Week 16

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). Higher scores indicate worsening.

Secondary outcomes

Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)

Time frame: Baseline, Week 16

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. Lower scores indicate worsening.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Nov 27, 2012
Registry last updated: Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed