An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00814801
First received: December 24, 2008
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: March 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Placebo
Drug: Galantamine 16 mg/day
Drug: Galantamine 24 mg/day

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Group No text entered.
Galantamine Group 1 Galantamine 16 mg/day
Galantamine Group 2 Galantamine 24 mg/day

Participant Flow:   Overall Study
    Placebo Group     Galantamine Group 1     Galantamine Group 2  
STARTED     194     192     194  
COMPLETED     160     154     151  
NOT COMPLETED     34     38     43  
Adverse Event                 15                 16                 19  
Withdrawal by Subject                 9                 11                 14  
Inappropriate as a subject                 1                 1                 1  
Change of patients for CIBIC plus-J                 1                 1                 0  
Missing or change of caregiver                 6                 2                 4  
Non-compliance                 0                 1                 1  
Not specified                 2                 6                 4  



  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 Group No text entered.
Galantamine Group 1 Galantamine 16 mg/day
Galantamine Group 2 Galantamine 24 mg/day
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Galantamine Group 1     Galantamine Group 2     Total  
Number of Participants  
[units: participants]
  191     191     192     574  
Age [1]
[units: years]
Mean ± Standard Deviation
  75.5  ± 7.6     75.6  ± 8.4     74.6  ± 8.8     75.2  ± 8.3  
Gender [2]
[units: participants]
       
Female     132     125     145     402  
Male     59     66     47     172  
[1] Six participants were excluded from the randomized patients as no evaluation on both ADAS and CIBIC was made after treatment with study medication.
[2] Six participants were excluded from the randomized patients as no evaluation on both Alzheimer's disease assessment scale (ADAS) and Clinician's Interview-Based Impression of Change (CIBIC) was made after treatment with study medication.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)   [ Time Frame: Baseline and 24 weeks ]

2.  Primary:   Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)   [ Time Frame: 24 weeks ]

3.  Secondary:   Change From Baseline in the Disability Assessment for Dementia (DAD)   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)   [ Time Frame: Baseline and 24 weeks ]

5.  Secondary:   Change From Baseline in the Mental Function Impairment Scale (MENFIS)   [ Time Frame: Baseline and 24 weeks ]


  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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  More Information
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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
Organization: Janssen Pharm KK Japan
phone: 81-3-4411-5717


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00814801     History of Changes
Other Study ID Numbers: CR010297, GAL-JPN-5
Study First Received: December 24, 2008
Results First Received: March 13, 2012
Last Updated: March 31, 2014
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center