Clinical trial NCT01734395: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Caregiver's Burden in Alzheimer's disease
Galantamine
Razadyne
Reminyl
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 1882
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease

Brief summary: 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.

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 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)

Primary outcomes:
measure: Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)
timeFrame: Baseline (Week 1 [Day 1]), Week 16
measure: Change From Baseline at Week 16 in Burden Interview (BI) Scores
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: