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
NCT01734395, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01734395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01734395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01734395
- Status
- Completed
- Enrollment
- 1,882 participants, actual
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Conditions
- Alzheimer's Disease
- Interventions
- Galantamine
- First posted
- 2012-11-27
- Last updated
- 2013-08-05
- Results first posted
- 2013-08-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | Baseline (Week 1 [Day 1]), Week 16 | 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. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline at Week 16 in Burden Interview (BI) Scores | Baseline, Week 16 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | Baseline, Week 16 | FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | Galantamine | -1.19 | Standard Deviation 4.56 | Units on a scale | |
| Change From Baseline at Week 16 in Burden Interview (BI) Scores | Galantamine | 1.48 | Standard Deviation 10.69 | Units on a scale | |
| Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | Galantamine | -0.69 | Standard Deviation 2.43 | Units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Galantamine | 1,882 | |
| Overall Study | COMPLETED | Galantamine | 1,472 | |
| Overall Study | NOT COMPLETED | Galantamine | 410 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiac failure congestive | Cardiac disorders | Galantamine | 1 | 1,882 | 1 |
| serious | Sepsis | Infections and infestations | Galantamine | 1 | 1,882 | 1 |
| serious | Septic shock | Infections and infestations | Galantamine | 1 | 1,882 | 1 |
| serious | Asthenia | General disorders | Galantamine | 2 | 1,882 | 2 |
| serious | Death | General disorders | Galantamine | 1 | 1,882 | 1 |
| serious | Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Galantamine | 1 | 1,882 | 1 |
| serious | Cholecystitis | Hepatobiliary disorders | Galantamine | 1 | 1,882 | 1 |
| serious | Cerebrovascular accident | Nervous system disorders | Galantamine | 1 | 1,882 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Galantamine | ||
| Total, other adverse events | Galantamine | 0 | 1,882 |
| Total, serious adverse events | Galantamine | 7 | 1,882 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01734395
GET https://conductscience.org/api/trials/v1/NCT01734395/registered