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Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00959192
First received: August 13, 2009
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Biological: ACC-001
Other: QS-21

  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
No text entered.

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
ACC-001 3 Micrograms + QS-21 A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
ACC-001 10 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
ACC-001 30 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
QS-21 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12

Participant Flow:   Overall Study
    ACC-001 3 Micrograms + QS-21   ACC-001 10 Micrograms + QS-21   ACC-001 30 Micrograms + QS-21   QS-21
STARTED   6   9   9   8 
COMPLETED   4   8   6   7 
NOT COMPLETED   2   1   3   1 
Adverse Event                1                1                1                0 
Investigator Request                1                0                0                0 
Caregiver Request                0                0                2                1 



  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
ACC-001 3 Micrograms + QS-21 A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
ACC-001 10 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
ACC-001 30 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
QS-21 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Total Total of all reporting groups

Baseline Measures
   ACC-001 3 Micrograms + QS-21   ACC-001 10 Micrograms + QS-21   ACC-001 30 Micrograms + QS-21   QS-21   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   9   9   8   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.50  (8.73)   68.00  (10.34)   74.33  (6.69)   64.75  (7.15)   69.81  (8.83) 
Gender 
[Units: Participants]
         
Female   6   6   6   7   25 
Male   0   3   3   1   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Treatment-emergent Adverse Events (AEs) by Severity   [ Time Frame: Baseline up to 24 months ]

2.  Primary:   Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data   [ Time Frame: Baseline up to 24 months ]

3.  Primary:   Number of Participants With Abnormalities in Neurological Examination   [ Time Frame: Baseline up to 24 months ]

4.  Secondary:   Anti-a-beta IgG Titer at Specified Visits   [ Time Frame: Baseline up to 24 months ]

5.  Secondary:   Anti-a-beta IgM Titer at Specified Visits   [ Time Frame: Baseline up to 24 months ]

6.  Other Pre-specified:   The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.   [ Time Frame: Baseline up to 24 months ]

7.  Other Pre-specified:   The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.   [ Time Frame: Baseline up to 24 months ]

8.  Other Pre-specified:   The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.   [ Time Frame: Baseline up to 24 months ]

9.  Other Pre-specified:   The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.   [ Time Frame: Baseline up to 24 months ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00959192     History of Changes
Other Study ID Numbers: 3134K1-2206
B2571009 ( Other Identifier: Alias Study Number )
Study First Received: August 13, 2009
Results First Received: May 9, 2014
Last Updated: November 30, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency