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A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00464334
First received: April 20, 2007
Last updated: September 24, 2015
Last verified: September 2015
History of Changes
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Diagnostic
Condition: Alzheimer Disease
Interventions: Biological: V950
Biological: ISCOMATRIX™
Biological: Placebo to V950

  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
Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Participant Flow:   Overall Study
    Placebo to V950/IMX 0 mcg   Placebo to V950/IMX 16 mcg   V950 0.5 mcg/IMX 0 mcg   V950 0.5 mcg/IMX 16 mcg   V950 0.5 mcg/IMX 47 mcg   V950 0.5 mcg/IMX 94 mcg   V950 5 mcg/IMX 0 mcg   V950 5 mcg/IMX 16 mcg   V950 5 mcg/IMX 47 mcg   V950 50 mcg/IMX 0 mcg   V950 50 mcg/IMX 16 mcg
STARTED   5   13   8   8   7   7   9   8   8   5   8 
COMPLETED   4   5   3   4   3   3   6   7   2   4   4 
NOT COMPLETED   1   8   5   4   4   4   3   1   6   1   4 
Adverse Event                0                0                0                1                1                1                0                0                2                1                2 
Lack of Efficacy                0                1                0                0                0                0                0                0                0                0                0 
Lost to Follow-up                0                0                1                0                1                0                1                0                0                0                2 
Progressive Disease                0                0                0                0                0                1                0                0                1                0                0 
Study Terminated by Sponsor                0                0                0                1                0                0                0                0                0                0                0 
Withdrawal by Subject                1                7                4                2                2                2                2                1                3                0                0 



  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.
No text entered.

Reporting Groups
  Description
Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg
Total Total of all reporting groups

Baseline Measures
   Placebo to V950/IMX 0 mcg   Placebo to V950/IMX 16 mcg   V950 0.5 mcg/IMX 0 mcg   V950 0.5 mcg/IMX 16 mcg   V950 0.5 mcg/IMX 47 mcg   V950 0.5 mcg/IMX 94 mcg   V950 5 mcg/IMX 0 mcg   V950 5 mcg/IMX 16 mcg   V950 5 mcg/IMX 47 mcg   V950 50 mcg/IMX 0 mcg   V950 50 mcg/IMX 16 mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 5   13   8   8   7   7   9   8   8   5   8   86 
Age 
[Units: Years]
Mean (Standard Deviation) 		 73.6  (10.69)   70.7  (9.6)   76.9  (4.39)   73.6  (8.07)   76.1  (8.01)   73.4  (10.89)   72.6  (9.26)   72.5  (10.10)   81.5  (5.48)   70.6  (8.38)   75.5  (10.04)   74.2  (8.85) 
Gender 
[Units: Participants]
 		                       
Female   3   7   3   5   5   6   4   5   1   3   3   45 
Male   2   6   5   3   2   1   5   3   7   2   5   41 


  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 4 years after first dose of vaccine ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 6 months after first dose of vaccine ]
  Show Outcome Measure 2

3.  Primary:   Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7   [ Time Frame: Month 7 ]
  Show Outcome Measure 3

4.  Primary:   Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies   [ Time Frame: Baseline and Month 7 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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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