An observational study in Alzheimer's Disease, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-08-05.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 1,882 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Alzheimer's disease
Exclusion Criteria:
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.
Also known as: Razadyne, Reminyl
Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)
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.
Time frame: Baseline (Week 1 [Day 1]), Week 16
Change From Baseline at Week 16 in Burden Interview (BI) Scores
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.
Time frame: Baseline, Week 16
Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)
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.
Time frame: Baseline, Week 16
1,882 participants were recruited to the 84 study centers.
| Milestone | Galantamine |
|---|---|
| Started | 1882 |
| Completed | 1472 |
| Not completed | 410 |
| Withdrew: Other | 65 |
| Withdrew: Lost to follow-up | 287 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Adverse event | 40 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Missing the reasons for not completed | 3 |
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.
| Units on a scale | Galantamine |
|---|---|
| Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | -1.19 ± 4.56 |
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.
| Units on a scale | Galantamine |
|---|---|
| Change From Baseline at Week 16 in Burden Interview (BI) Scores | 1.48 ± 10.69 |
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.
| Units on a scale | Galantamine |
|---|---|
| Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | -0.69 ± 2.43 |
Collected over Up to 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Galantamine | — | 7/1,882 (0.4%) | 0/1,882 (0%) |
| Event | Galantamine |
|---|---|
| AstheniaGeneral disorders | 2/1882 |
| Cardiac failure congestiveCardiac disorders | 1/1882 |
| SepsisInfections and infestations | 1/1882 |
| Septic shockInfections and infestations | 1/1882 |
| DeathGeneral disorders | 1/1882 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/1882 |
| CholecystitisHepatobiliary disorders | 1/1882 |
| Cerebrovascular accidentNervous system disorders | 1/1882 |
Baseline characteristics were determined in Full Analysis Set (FAS) population. Out of 1,882 enrolled participants, 1,393 participants were included in the FAS and 489 participants were excluded due to violation of the inclusion/exclusion criteria.
| Age Continuous(Years) | Galantamine |
|---|---|
| Mean | 74.11 ± 8.80 |
| Sex: Female, Male(Participants) | Galantamine |
|---|---|
| Female | 895 |
| Male | 498 |
| Severity of symptoms of dementia(Participants) | Galantamine |
|---|---|
| Suspected dementia | 27 |
| Moderate dementia | 668 |
| Severe dementia | 94 |
| Late (very severe) dementia | 6 |
| Mild dementia | 598 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Korea, Ltd., Korea