Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, Caregiver's Burden in Alzheimer's disease, Galantamine, Razadyne, Reminyl
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.
Interventions
DRUGGalantamine
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.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | 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. |
Participant flow
Recruitment details
1,882 participants were recruited to the 84 study centers.
Pre-assignment details
Out of 1,882 participants, 489 participants violated the inclusion/exclusion criteria and were excluded from the full analysis set (FAS). 1,472 participants completed the study. Total 1,393 participants were included in the FAS population.
Participants by arm
| Arm | Count |
|---|---|
| Galantamine Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks. | 1,393 |
| Total | 1,393 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 40 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 287 |
| Overall Study | Missing the reasons for not completed | 3 |
| Overall Study | Other | 65 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Galantamine |
|---|---|
| Age Continuous | 74.11 Years STANDARD_DEVIATION 8.8 |
| Severity of symptoms of dementia Late (very severe) dementia | 6 Participants |
| Severity of symptoms of dementia Mild dementia | 598 Participants |
| Severity of symptoms of dementia Moderate dementia | 668 Participants |
| Severity of symptoms of dementia Severe dementia | 94 Participants |
| Severity of symptoms of dementia Suspected dementia | 27 Participants |
| Sex: Female, Male Female | 895 Participants |
| Sex: Female, Male Male | 498 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,882 |
| serious Total, serious adverse events | 7 / 1,882 |
Outcome results
Primary
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
Population: FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | -1.19 Units on a scale | Standard Deviation 4.56 |
p-value: <0.000195% CI: [-1.4262, -0.9467]t-test, 2 sided
Primary
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
Population: FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Baseline at Week 16 in Burden Interview (BI) Scores | 1.48 Units on a scale | Standard Deviation 10.69 |
p-value: <0.000195% CI: [0.9188, 2.0438]t-test, 2 sided
Secondary
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
Population: FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | -0.69 Units on a scale | Standard Deviation 2.43 |
p-value: <0.000195% CI: [-0.814, -0.5586]t-test, 2 sided