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

This study has been terminated.
(Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00679627
First received: May 15, 2008
Last updated: September 10, 2013
Last verified: September 2013
Results First Received: April 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Galantamine
Drug: Placebo

  Participant Flow


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

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

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

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

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 ]

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 ]

7.  Secondary:   Change From Baseline in Institutional Status   [ Time Frame: Baseline, 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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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