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: October 22, 2013
Last verified: October 2013
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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 ]

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00464334     History of Changes
Other Study ID Numbers: V950-001, 2007_518
Study First Received: April 20, 2007
Results First Received: November 19, 2012
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration