Trial Outcomes & Findings for 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 NCT01734395)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1882 participants

Primary outcome timeframe

Baseline (Week 1 [Day 1]), Week 16

Results posted on

2013-08-05

Participant Flow

1,882 participants were recruited to the 84 study centers.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1882
Overall Study COMPLETED	1472
Overall Study NOT COMPLETED	410

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Other	65
Overall Study Lost to Follow-up	287
Overall Study Lack of Efficacy	5
Overall Study Adverse Event	40
Overall Study Withdrawal by Subject	10
Overall Study Missing the reasons for not completed	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galantamine n=1393 Participants Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
Age Continuous	74.11 Years STANDARD_DEVIATION 8.80 • n=5 Participants
Sex: Female, Male Female	895 Participants n=5 Participants
Sex: Female, Male Male	498 Participants n=5 Participants
Severity of symptoms of dementia Suspected dementia	27 Participants n=5 Participants
Severity of symptoms of dementia Moderate dementia	668 Participants n=5 Participants
Severity of symptoms of dementia Severe dementia	94 Participants n=5 Participants
Severity of symptoms of dementia Late (very severe) dementia	6 Participants n=5 Participants
Severity of symptoms of dementia Mild dementia	598 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Galantamine n=1393 Participants Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)	-1.19 Units on a scale Standard Deviation 4.56

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Galantamine n=1393 Participants Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
Change From Baseline at Week 16 in Burden Interview (BI) Scores	1.48 Units on a scale Standard Deviation 10.69

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria

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.

Outcome measures

Outcome measures
Measure	Galantamine n=1393 Participants Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)	-0.69 Units on a scale Standard Deviation 2.43

Adverse Events

Galantamine

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Galantamine n=1882 participants at risk Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
Cardiac disorders Cardiac failure congestive	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Infections and infestations Sepsis	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Infections and infestations Septic shock	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
General disorders Asthenia	0.11% 2/1882 • Number of events 2 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
General disorders Death	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Hepatobiliary disorders Cholecystitis	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Nervous system disorders Cerebrovascular accident	0.05% 1/1882 • Number of events 1 • Up to 16 weeks Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Director

Jan-Cil Korea

Phone: 82 2 2094

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60