Trial Outcomes & Findings for A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease (NCT NCT00679627)
NCT ID: NCT00679627
Last Updated: 2013-09-19
Results Overview
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2051 participants
Primary outcome timeframe
Baseline, Month 24
Results posted on
2013-09-19
Participant Flow
This study investigated the benefits and risks of long-term galantamine use in participants with Alzheimer's Disease. The study was conducted from 19 May 2008 to 20 May 2012 at 127 clinical centers in 13 countries. A total of 2051 participants were randomized to study treatment, of these 2045 received at least 1 dose of treatment.
The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.
Participant milestones
| Measure |
Placebo
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Overall Study
STARTED
|
1021
|
1024
|
|
Overall Study
COMPLETED
|
322
|
339
|
|
Overall Study
NOT COMPLETED
|
699
|
685
|
Reasons for withdrawal
| Measure |
Placebo
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Overall Study
Death
|
41
|
29
|
|
Overall Study
Adverse Event
|
43
|
53
|
|
Overall Study
Withdrawal by Subject
|
168
|
172
|
|
Overall Study
Lost to Follow-up
|
22
|
26
|
|
Overall Study
Early Study Closure
|
425
|
405
|
Baseline Characteristics
A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=1021 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=1024 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
Total
n=2045 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
73.2 participants
STANDARD_DEVIATION 8.67 • n=93 Participants
|
73 participants
STANDARD_DEVIATION 8.88 • n=4 Participants
|
73.1 participants
STANDARD_DEVIATION 8.77 • n=27 Participants
|
|
Age, Customized
<61
|
112 participants
n=93 Participants
|
112 participants
n=4 Participants
|
224 participants
n=27 Participants
|
|
Age, Customized
61-<76
|
467 participants
n=93 Participants
|
466 participants
n=4 Participants
|
933 participants
n=27 Participants
|
|
Age, Customized
>=76
|
442 participants
n=93 Participants
|
446 participants
n=4 Participants
|
888 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
654 Participants
n=93 Participants
|
671 Participants
n=4 Participants
|
1325 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
367 Participants
n=93 Participants
|
353 Participants
n=4 Participants
|
720 Participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
33 participants
n=93 Participants
|
34 participants
n=4 Participants
|
67 participants
n=27 Participants
|
|
Region of Enrollment
Estonia
|
53 participants
n=93 Participants
|
51 participants
n=4 Participants
|
104 participants
n=27 Participants
|
|
Region of Enrollment
France
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
218 participants
n=93 Participants
|
221 participants
n=4 Participants
|
439 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
35 participants
n=93 Participants
|
36 participants
n=4 Participants
|
71 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
25 participants
n=93 Participants
|
24 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
Region of Enrollment
Latvia
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Lithuania
|
23 participants
n=93 Participants
|
21 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
84 participants
n=93 Participants
|
84 participants
n=4 Participants
|
168 participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
274 participants
n=93 Participants
|
271 participants
n=4 Participants
|
545 participants
n=27 Participants
|
|
Region of Enrollment
Slovakia
|
85 participants
n=93 Participants
|
88 participants
n=4 Participants
|
173 participants
n=27 Participants
|
|
Region of Enrollment
Slovenia
|
13 participants
n=93 Participants
|
13 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Region of Enrollment
Ukraine
|
166 participants
n=93 Participants
|
168 participants
n=4 Participants
|
334 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
|
-2.14 Scores on scale
Standard Deviation 4.340
|
-1.41 Scores on scale
Standard Deviation 4.050
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.
An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.
Outcome measures
| Measure |
Placebo
n=1021 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=1024 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
The Number of Deaths Reported in Participants
|
56 Number of Participants
|
33 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
|
-0.28 Scores on scale
Standard Deviation 2.938
|
0.15 Scores on scale
Standard Deviation 2.725
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in Disability Assessment in Dementia (DAD) Scores
|
-10.81 Scores on scale
Standard Deviation 18.268
|
-8.16 Scores on scale
Standard Deviation 17.251
|
SECONDARY outcome
Timeframe: Baseline, Months 12 and 24Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.
The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants "home with friend or relative" using the APAS-CarB.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Home with friend or relative - Baseline
|
62.1 Percentage of participants
|
62.8 Percentage of participants
|
|
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Home with friend or relative - Month 12
|
61.4 Percentage of participants
|
61.8 Percentage of participants
|
|
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Home with friend or relative - Month 24
|
55.3 Percentage of participants
|
60.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 12 and 24Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
The table below presents the number of days that caregiving activities were provided during the past week.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Provided caregiving during past week - Baseline
|
5.91 Days
Standard Deviation 2.094
|
5.77 Days
Standard Deviation 2.241
|
|
Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Provided caregiving during past week - Month 12
|
6.06 Days
Standard Deviation 1.964
|
6.07 Days
Standard Deviation 1.969
|
|
Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Provided caregiving during past week - Month 24
|
6.13 Days
Standard Deviation 1.952
|
6.20 Days
Standard Deviation 1.830
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
This table describes the number of participants who were reported as institutionalized at baseline and Month 24.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in Institutional Status
Baseline
|
1 Number of Participants
|
0 Number of Participants
|
|
Change From Baseline in Institutional Status
Month 24
|
5 Number of Participants
|
6 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation \[each with a maximum score of 5\] was used). A higher score compared with baseline indicates less impairment.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Orientation
|
-0.96 Scores on scale
Standard Deviation 2.320
|
-0.76 Scores on scale
Standard Deviation 2.128
|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Registration
|
-0.20 Scores on scale
Standard Deviation 0.771
|
-0.16 Scores on scale
Standard Deviation 0.692
|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Attention and Calculation
|
-0.46 Scores on scale
Standard Deviation 1.526
|
-0.16 Scores on scale
Standard Deviation 1.561
|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Recall
|
0.00 Scores on scale
Standard Deviation 1.013
|
0.10 Scores on scale
Standard Deviation 1.070
|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Language
|
-0.93 Scores on scale
Standard Deviation 1.895
|
-0.68 Scores on scale
Standard Deviation 1.867
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Outcome measures
| Measure |
Placebo
n=906 Participants
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=906 Participants
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Initiation
|
-13.53 Scores on scale
Standard Deviation 22.993
|
-9.60 Scores on scale
Standard Deviation 20.660
|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Planning and Organization
|
-13.14 Scores on scale
Standard Deviation 24.565
|
-9.96 Scores on scale
Standard Deviation 23.154
|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Effective Performance
|
-13.82 Scores on scale
Standard Deviation 21.975
|
-10.82 Scores on scale
Standard Deviation 19.959
|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Basic
|
-14.24 Scores on scale
Standard Deviation 24.093
|
-9.84 Scores on scale
Standard Deviation 21.899
|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Instrumental
|
-13.52 Scores on scale
Standard Deviation 23.210
|
-10.72 Scores on scale
Standard Deviation 21.714
|
|
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Leisure
|
-13.02 Scores on scale
Standard Deviation 35.370
|
-10.46 Scores on scale
Standard Deviation 32.769
|
Adverse Events
Placebo
Serious events: 123 serious events
Other events: 115 other events
Deaths: 0 deaths
Galantamine
Serious events: 129 serious events
Other events: 168 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=1021 participants at risk
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=1024 participants at risk
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Cardiac disorders
Arrhythmia
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Bradycardia
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Cardiac disorders
Cardiac Failure
|
0.29%
3/1021 • Over 2 years
|
0.98%
10/1024 • Over 2 years
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.20%
2/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.29%
3/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.39%
4/1021 • Over 2 years
|
0.29%
3/1024 • Over 2 years
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.29%
3/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.20%
2/1021 • Over 2 years
|
0.59%
6/1024 • Over 2 years
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Postinfarction Angina
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Cardiac disorders
Tachyarrhythmia
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Eye disorders
Cataract Subcapsular
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Eye disorders
Glaucoma
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Eye disorders
Lens Disorder
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Anal Polyp
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Enterocolitis Haemorrhagic
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Gastrointestinal disorders
Haemorrhagic Erosive Gastritis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Gastrointestinal disorders
Intestinal Stenosis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Oesophageal Achalasia
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
General disorders
Abasia
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
General disorders
Death
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
General disorders
Hypothermia
|
0.20%
2/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
General disorders
Inflammation
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
General disorders
Multi-Organ Failure
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
General disorders
Pyrexia
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
General disorders
Sudden Death
|
0.29%
3/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Infections and infestations
Abscess
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Infections and infestations
Bronchopneumonia
|
0.29%
3/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Infections and infestations
Ear Infection
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Infections and infestations
Herpes Zoster
|
0.10%
1/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Infections and infestations
Peritonitis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Infections and infestations
Pneumonia
|
0.59%
6/1021 • Over 2 years
|
0.78%
8/1024 • Over 2 years
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Infections and infestations
Sepsis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Infections and infestations
Tuberculosis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Carbon Monoxide Poisoning
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Chemical Poisoning
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Exposure to Toxic Agent
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
3/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.29%
3/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.29%
3/1021 • Over 2 years
|
0.29%
3/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.20%
2/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.29%
3/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.10%
1/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Urethral Injury
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Injury, poisoning and procedural complications
Wound Haemorrhage
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Investigations
Weight Decreased
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/1021 • Over 2 years
|
0.39%
4/1024 • Over 2 years
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.20%
2/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.20%
2/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Compression
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.20%
2/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal Neoplasm
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Adenoma
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Altered State of Consciousness
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Cerebral Arteriosclerosis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Cerebral Infarction
|
0.20%
2/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.20%
2/1021 • Over 2 years
|
0.39%
4/1024 • Over 2 years
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Coma
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Dementia
|
0.20%
2/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
1.2%
12/1021 • Over 2 years
|
0.88%
9/1024 • Over 2 years
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Epilepsy
|
0.29%
3/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Ischaemic Stroke
|
0.78%
8/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Nervous system disorders
Loss of Consciousness
|
0.10%
1/1021 • Over 2 years
|
0.29%
3/1024 • Over 2 years
|
|
Nervous system disorders
Polyneuropathy
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Nervous system disorders
Syncope
|
0.29%
3/1021 • Over 2 years
|
0.29%
3/1024 • Over 2 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.29%
3/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Psychiatric disorders
Adjustment Disorder
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Aggression
|
0.10%
1/1021 • Over 2 years
|
0.29%
3/1024 • Over 2 years
|
|
Psychiatric disorders
Agitation
|
0.20%
2/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Delirium
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Psychiatric disorders
Restlessness
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Renal and urinary disorders
Incontinence
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Renal and urinary disorders
Nephritis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Reproductive system and breast disorders
Scrotal Disorder
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Reproductive system and breast disorders
Vulval Leukoplakia
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Lung Injury
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.10%
1/1021 • Over 2 years
|
0.49%
5/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Surgical and medical procedures
Carotid Artery Stent Removal
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Vascular disorders
Circulatory Collapse
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Vascular disorders
Essential Hypertension
|
0.00%
0/1021 • Over 2 years
|
0.20%
2/1024 • Over 2 years
|
|
Vascular disorders
Haemorrhagic Infarction
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Vascular disorders
Hypertension
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Vascular disorders
Hypotension
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Vascular disorders
Malignant Hypertension
|
0.10%
1/1021 • Over 2 years
|
0.10%
1/1024 • Over 2 years
|
|
Vascular disorders
Pallor
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.10%
1/1021 • Over 2 years
|
0.00%
0/1024 • Over 2 years
|
Other adverse events
| Measure |
Placebo
n=1021 participants at risk
During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
|
Galantamine
n=1024 participants at risk
During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
4.7%
48/1021 • Over 2 years
|
5.6%
57/1024 • Over 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.4%
24/1021 • Over 2 years
|
8.3%
85/1024 • Over 2 years
|
|
Nervous system disorders
Headache
|
5.7%
58/1021 • Over 2 years
|
5.7%
58/1024 • Over 2 years
|
Additional Information
Director, Clinical Research
Johnson & Johnson Pharmaceutical Research & Development
Phone: 1 609-730-7674
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER