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A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00679627
Recruitment Status : Terminated (Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial)
First Posted : May 19, 2008
Results First Posted : September 2, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Galantamine
Drug: Placebo
Enrollment 2051
Recruitment Details 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.
Pre-assignment Details The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 1021 1024
Completed 322 339
Not Completed 699 685
Reason Not Completed
Death             41             29
Adverse Event             43             53
Withdrawal by Subject             168             172
Lost to Follow-up             22             26
Early Study Closure             425             405
Arm/Group Title Placebo Galantamine Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 1021 1024 2045
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 1021 participants 1024 participants 2045 participants
73.2  (8.67) 73  (8.88) 73.1  (8.77)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1021 participants 1024 participants 2045 participants
<61 112 112 224
61-<76 467 466 933
>=76 442 446 888
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1021 participants 1024 participants 2045 participants
Female
654
  64.1%
671
  65.5%
1325
  64.8%
Male
367
  35.9%
353
  34.5%
720
  35.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1021 participants 1024 participants 2045 participants
Czech Republic 33 34 67
Estonia 53 51 104
France 10 11 21
Germany 218 221 439
Greece 35 36 71
Italy 25 24 49
Latvia 2 2 4
Lithuania 23 21 44
Romania 84 84 168
Russia 274 271 545
Slovakia 85 88 173
Slovenia 13 13 26
Ukraine 166 168 334
1.Primary Outcome
Title Change From Baseline in the Mini–Mental State Examination (MMSE) Score
Hide Description 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.
Time Frame Baseline, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Scores on scale
-2.14  (4.340) -1.41  (4.050)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title The Number of Deaths Reported in Participants
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 1021 1024
Measure Type: Number
Unit of Measure: Number of Participants
56 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.37 to 0.89
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Mini–Mental State Examination (MMSE) Score
Hide Description 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.
Time Frame Baseline, Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Scores on scale
-0.28  (2.938) 0.15  (2.725)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Disability Assessment in Dementia (DAD) Scores
Hide Description 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.
Time Frame Baseline, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Scores on scale
-10.81  (18.268) -8.16  (17.251)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Hide Description 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.
Time Frame Baseline, Months 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Measure Type: Number
Unit of Measure: Percentage of participants
Home with friend or relative - Baseline 62.1 62.8
Home with friend or relative - Month 12 61.4 61.8
Home with friend or relative - Month 24 55.3 60.1
6.Secondary Outcome
Title Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Hide Description The table below presents the number of days that caregiving activities were provided during the past week.
Time Frame Baseline, Months 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Days
Provided caregiving during past week - Baseline 5.91  (2.094) 5.77  (2.241)
Provided caregiving during past week - Month 12 6.06  (1.964) 6.07  (1.969)
Provided caregiving during past week - Month 24 6.13  (1.952) 6.20  (1.830)
7.Secondary Outcome
Title Change From Baseline in Institutional Status
Hide Description This table describes the number of participants who were reported as institutionalized at baseline and Month 24.
Time Frame Baseline, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Measure Type: Number
Unit of Measure: Number of Participants
Baseline 1 0
Month 24 5 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments Baseline
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.835
Comments Month 24
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Hide Description 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.
Time Frame Baseline, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Scores on scale
Orientation -0.96  (2.320) -0.76  (2.128)
Registration -0.20  (0.771) -0.16  (0.692)
Attention and Calculation -0.46  (1.526) -0.16  (1.561)
Recall 0.00  (1.013) 0.10  (1.070)
Language -0.93  (1.895) -0.68  (1.867)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments Orientation subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments Registration subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Attention and Calculation subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments Recall subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments Language subscale
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Hide Description 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.
Time Frame Baseline, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 906 906
Mean (Standard Deviation)
Unit of Measure: Scores on scale
Initiation -13.53  (22.993) -9.60  (20.660)
Planning and Organization -13.14  (24.565) -9.96  (23.154)
Effective Performance -13.82  (21.975) -10.82  (19.959)
Basic -14.24  (24.093) -9.84  (21.899)
Instrumental -13.52  (23.210) -10.72  (21.714)
Leisure -13.02  (35.370) -10.46  (32.769)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments Initiation subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments Planning and Organization subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Effective Performance subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Basic subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments Instrumental subscale
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Galantamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments Leisure subscale
Method ANCOVA
Comments [Not Specified]
Time Frame Over 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Galantamine
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo Galantamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Galantamine
Affected / at Risk (%) Affected / at Risk (%)
Total   123/1021 (12.05%)   129/1024 (12.60%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Arrhythmia * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Arteriosclerosis Coronary Artery * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Atrial Fibrillation * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Bradyarrhythmia * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Bradycardia * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Cardiac Arrest * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Cardiac Failure * 1  3/1021 (0.29%)  10/1024 (0.98%) 
Cardiac Failure Acute * 1  2/1021 (0.20%)  2/1024 (0.20%) 
Cardio-Respiratory Arrest * 1  3/1021 (0.29%)  0/1024 (0.00%) 
Cardiopulmonary Failure * 1  4/1021 (0.39%)  3/1024 (0.29%) 
Cardiovascular Insufficiency * 1  3/1021 (0.29%)  1/1024 (0.10%) 
Ischaemic Cardiomyopathy * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Myocardial Infarction * 1  2/1021 (0.20%)  6/1024 (0.59%) 
Myocardial Ischaemia * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Postinfarction Angina * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Tachyarrhythmia * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Eye disorders     
Cataract * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Cataract Subcapsular * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Glaucoma * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Lens Disorder * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Gastrointestinal disorders     
Anal Polyp * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Colitis Ischaemic * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Diarrhoea * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Duodenal Ulcer Perforation * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Dysphagia * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Enterocolitis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Enterocolitis Haemorrhagic * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Faecal Incontinence * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Gastric Ulcer * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Gastric Ulcer Haemorrhage * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Gastroduodenitis * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Haemorrhagic Erosive Gastritis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Haemorrhoidal Haemorrhage * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Haemorrhoids * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Ileus * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Inguinal Hernia * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Intestinal Stenosis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Nausea * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Oesophageal Achalasia * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Pancreatitis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Peritoneal Haemorrhage * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Upper Gastrointestinal Haemorrhage * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Varices Oesophageal * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Vomiting * 1  1/1021 (0.10%)  1/1024 (0.10%) 
General disorders     
Abasia * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Death * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Hypothermia * 1  2/1021 (0.20%)  0/1024 (0.00%) 
Inflammation * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Multi-Organ Failure * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Oedema Peripheral * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Pyrexia * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Sudden Death * 1  3/1021 (0.29%)  1/1024 (0.10%) 
Hepatobiliary disorders     
Bile Duct Stone * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Cholecystitis * 1  1/1021 (0.10%)  2/1024 (0.20%) 
Infections and infestations     
Abscess * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Bronchitis * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Bronchopneumonia * 1  3/1021 (0.29%)  2/1024 (0.20%) 
Clostridium Difficile Colitis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Ear Infection * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Gastroenteritis Rotavirus * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Gastrointestinal Infection * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Herpes Zoster * 1  1/1021 (0.10%)  2/1024 (0.20%) 
Peritonitis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Pneumonia * 1  6/1021 (0.59%)  8/1024 (0.78%) 
Post Procedural Infection * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Sepsis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Tuberculosis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Urinary Tract Infection * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Urosepsis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Injury, poisoning and procedural complications     
Accidental Overdose * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Carbon Monoxide Poisoning * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Chemical Poisoning * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Exposure to Toxic Agent * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Fall * 1  3/1021 (0.29%)  2/1024 (0.20%) 
Femoral Neck Fracture * 1  3/1021 (0.29%)  2/1024 (0.20%) 
Femur Fracture * 1  3/1021 (0.29%)  3/1024 (0.29%) 
Forearm Fracture * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Hand Fracture * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Head Injury * 1  2/1021 (0.20%)  1/1024 (0.10%) 
Hip Fracture * 1  3/1021 (0.29%)  1/1024 (0.10%) 
Humerus Fracture * 1  1/1021 (0.10%)  2/1024 (0.20%) 
Injury * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Joint Dislocation * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Lower Limb Fracture * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Lumbar Vertebral Fracture * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Multiple Fractures * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Patella Fracture * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Rib Fracture * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Skeletal Injury * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Spinal Fracture * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Subdural Haematoma * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Subdural Haemorrhage * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Upper Limb Fracture * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Urethral Injury * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Wound Haemorrhage * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Investigations     
Blood Pressure Increased * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Weight Decreased * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Dehydration * 1  1/1021 (0.10%)  4/1024 (0.39%) 
Diabetes Mellitus * 1  2/1021 (0.20%)  2/1024 (0.20%) 
Hyperglycaemia * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  2/1021 (0.20%)  1/1024 (0.10%) 
Bone Pain * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Intervertebral Disc Compression * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Muscular Weakness * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Musculoskeletal Pain * 1  2/1021 (0.20%)  1/1024 (0.10%) 
Osteoarthritis * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Spinal Column Stenosis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Spinal Osteoarthritis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma Pancreas * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Breast Cancer * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Colon Cancer * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Hepatic Neoplasm Malignant * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Pancreatic Neoplasm * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Pharyngeal Neoplasm * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Prostatic Adenoma * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Rectal Cancer * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Salivary Gland Adenoma * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Nervous system disorders     
Altered State of Consciousness * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Cerebral Arteriosclerosis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Cerebral Haemorrhage * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Cerebral Infarction * 1  2/1021 (0.20%)  1/1024 (0.10%) 
Cerebrovascular Accident * 1  2/1021 (0.20%)  4/1024 (0.39%) 
Cerebrovascular Disorder * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Coma * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Dementia * 1  2/1021 (0.20%)  0/1024 (0.00%) 
Dementia Alzheimer's Type * 1  12/1021 (1.18%)  9/1024 (0.88%) 
Diabetic Neuropathy * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Epilepsy * 1  3/1021 (0.29%)  0/1024 (0.00%) 
Haemorrhage Intracranial * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Haemorrhagic Stroke * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Ischaemic Stroke * 1  8/1021 (0.78%)  2/1024 (0.20%) 
Loss of Consciousness * 1  1/1021 (0.10%)  3/1024 (0.29%) 
Polyneuropathy * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Presyncope * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Speech Disorder * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Syncope * 1  3/1021 (0.29%)  3/1024 (0.29%) 
Transient Ischaemic Attack * 1  3/1021 (0.29%)  2/1024 (0.20%) 
Vertebrobasilar Insufficiency * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Psychiatric disorders     
Abnormal Behaviour * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Adjustment Disorder * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Aggression * 1  1/1021 (0.10%)  3/1024 (0.29%) 
Agitation * 1  2/1021 (0.20%)  1/1024 (0.10%) 
Catatonia * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Confusional State * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Delirium * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Depression * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Disorientation * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Psychotic Disorder * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Restlessness * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Suicide Attempt * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Renal and urinary disorders     
Incontinence * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Nephritis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Renal Failure Acute * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Renal Failure Chronic * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Stress Urinary Incontinence * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Tubulointerstitial Nephritis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Urinary Incontinence * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Urinary Retention * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Pelvic Pain * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Scrotal Disorder * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Vulval Leukoplakia * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Lung Injury * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Aspiration * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Bronchitis Chronic * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Chronic Obstructive Pulmonary Disease * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Dyspnoea * 1  1/1021 (0.10%)  2/1024 (0.20%) 
Emphysema * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Pneumonia Aspiration * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Pneumothorax * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Pulmonary Embolism * 1  1/1021 (0.10%)  5/1024 (0.49%) 
Pulmonary Oedema * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Respiratory Failure * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Psoriasis * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Rash * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Surgical and medical procedures     
Carotid Artery Stent Removal * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Vascular disorders     
Arteriosclerosis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Circulatory Collapse * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Essential Hypertension * 1  0/1021 (0.00%)  2/1024 (0.20%) 
Haemorrhagic Infarction * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Hypertension * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Hypertensive Crisis * 1  0/1021 (0.00%)  1/1024 (0.10%) 
Hypotension * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Malignant Hypertension * 1  1/1021 (0.10%)  1/1024 (0.10%) 
Pallor * 1  1/1021 (0.10%)  0/1024 (0.00%) 
Peripheral Arterial Occlusive Disease * 1  1/1021 (0.10%)  0/1024 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Galantamine
Affected / at Risk (%) Affected / at Risk (%)
Total   115/1021 (11.26%)   168/1024 (16.41%) 
Ear and labyrinth disorders     
Vertigo * 1  48/1021 (4.70%)  57/1024 (5.57%) 
Gastrointestinal disorders     
Nausea * 1  24/1021 (2.35%)  85/1024 (8.30%) 
Nervous system disorders     
Headache * 1  58/1021 (5.68%)  58/1024 (5.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 1 609-730-7674
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00679627     History of Changes
Other Study ID Numbers: CR012463
GALALZ3005 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: May 15, 2008
First Posted: May 19, 2008
Results First Submitted: April 23, 2013
Results First Posted: September 2, 2013
Last Update Posted: September 19, 2013