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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Galantamine
STARTED   1021   1024 
COMPLETED   322   339 
NOT COMPLETED   699   685 
Death                41                29 
Adverse Event                43                53 
Withdrawal by Subject                168                172 
Lost to Follow-up                22                26 
Early Study Closure                425                405 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Galantamine   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 1021   1024   2045 
Age 
[Units: Participants]
Mean (Standard Deviation) 		 73.2  (8.67)   73  (8.88)   73.1  (8.77) 
Age, Customized 
[Units: Participants]
 		     
<61   112   112   224 
61-<76   467   466   933 
>=76   442   446   888 
Gender 
[Units: Participants]
 		     
Female   654   671   1325 
Male   367   353   720 
Region of Enrollment 
[Units: 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 


  Outcome Measures

1.  Primary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Score   [ Time Frame: Baseline, Month 24 ]
  Show Outcome Measure 1

2.  Primary:   The Number of Deaths Reported in Participants   [ Time Frame: Up to 2 years ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Score   [ Time Frame: Baseline, Month 6 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Disability Assessment in Dementia (DAD) Scores   [ Time Frame: Baseline, Month 24 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)   [ Time Frame: Baseline, Months 12 and 24 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)   [ Time Frame: Baseline, Months 12 and 24 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Institutional Status   [ Time Frame: Baseline, Month 24 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Change From Baseline in Institutional Status
Measure Description This table describes the number of participants who were reported as institutionalized at baseline and Month 24.
Time Frame Baseline, Month 24  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.

Reporting Groups
  Description
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.

Measured Values
   Placebo   Galantamine 
Participants Analyzed 
[Units: Participants]
 		 906   906 
Change From Baseline in Institutional Status 
[Units: Number of Participants]
 		   
Baseline   1   0 
Month 24   5   6 


Statistical Analysis 1 for Change From Baseline in Institutional Status
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.269
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Baseline

Statistical Analysis 2 for Change From Baseline in Institutional Status
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.835
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Month 24



8.  Secondary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)   [ Time Frame: Baseline, Month 24 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)   [ Time Frame: Baseline, Month 24 ]
  Show Outcome Measure 9


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 1 609-730-7674


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


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