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

This study has been terminated.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01238991
First received: October 21, 2010
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Biological: ACC-001

  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
The study enrolled those who completed the preceding studies (NCT00752232 and NCT00959192), where active vaccine ACC-001 (3, 10 or 30 μg) + adjuvant QS-21 (50 μg), as well as ACC-001, QS-21 and phosphate buffered saline (PBS) alone, were administered at Day 1, month 3, 6, 9 and 12 and at Day 1, month 1, 3, 6 and 12, respectively.

Reporting Groups
  Description
3 μg ACC-001+QS-21 A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
QS-21+(3 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
10 μg ACC-001+QS-21 A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
10 μg ACC-001+ (10 μg ACC-001+QS-21) A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
QS-21+(10 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
PBS+(10 μg ACC-001+QS-21) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
30 μg ACC-001+QS-21 A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
30 μg ACC-001+(30 μg ACC-001+QS-21) A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
QS-21+(30 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
PBS+(30 μg ACC-001+QS-21) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)

Participant Flow:   Overall Study
    3 μg ACC-001+QS-21     QS-21+(3 μg ACC-001+QS-21)     10 μg ACC-001+QS-21     10 μg ACC-001+ (10 μg ACC-001+QS-21)     QS-21+(10 μg ACC-001+QS-21)     PBS+(10 μg ACC-001+QS-21)     30 μg ACC-001+QS-21     30 μg ACC-001+(30 μg ACC-001+QS-21)     QS-21+(30 μg ACC-001+QS-21)     PBS+(30 μg ACC-001+QS-21)  
STARTED     7     3     11     6     5     2     8     5     4     2  
Received Treatment     7     3     11     6     5     2     8     5     4     2  
COMPLETED     5     3     5     4     3     2     0     0     0     0  
NOT COMPLETED     2     0     6     2     2     0     8     5     4     2  
Adverse Event                 1                 0                 3                 1                 1                 0                 1                 1                 0                 0  
Death                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 0                 0                 1                 0                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0  
Study Terminated by Sponsor                 0                 0                 0                 0                 1                 0                 7                 4                 2                 2  
Caregiver's request                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0  
Admission to a nursing home                 1                 0                 1                 0                 0                 0                 0                 0                 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
3 μg ACC-001+QS-21 A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
QS-21+(3 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
10 μg ACC-001+QS-21 A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
10 μg ACC-001+ (10 μg ACC-001+QS-21) A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
QS-21+(10 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
PBS+(10 μg ACC-001+QS-21) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
30 μg ACC-001+QS-21 A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
30 μg ACC-001+(30 μg ACC-001+QS-21) A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
QS-21+(30 μg ACC-001+QS-21) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
PBS+(30 μg ACC-001+QS-21) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Total Total of all reporting groups

Baseline Measures
    3 μg ACC-001+QS-21     QS-21+(3 μg ACC-001+QS-21)     10 μg ACC-001+QS-21     10 μg ACC-001+ (10 μg ACC-001+QS-21)     QS-21+(10 μg ACC-001+QS-21)     PBS+(10 μg ACC-001+QS-21)     30 μg ACC-001+QS-21     30 μg ACC-001+(30 μg ACC-001+QS-21)     QS-21+(30 μg ACC-001+QS-21)     PBS+(30 μg ACC-001+QS-21)     Total  
Number of Participants  
[units: participants]
  7     3     11     6     5     2     8     5     4     2     53  
Age  
[units: years]
Mean (Standard Deviation)
  69  (9.8)     73.3  (9.2)     67.5  (9.8)     69.5  (6.9)     65.2  (6.7)     70.5  (7.8)     73.9  (5.4)     71.2  (2)     64  (7.1)     68.5  (2.1)     69.2  (7.6)  
Gender  
[units: Participants]
                     
Female     4     3     8     4     3     2     4     3     4     1     36  
Male     3     0     3     2     2     0     4     2     0     1     17  



  Outcome Measures
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1.  Primary:   Number 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 of the preceding studies through 24 months of this study ]

4.  Other Pre-specified:   Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits   [ Time Frame: Baseline of preceding studies to month 24 of this study (Week 210) ]

5.  Other Pre-specified:   Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits   [ Time Frame: Baseline of preceding studies to month 24 of this study (Week 210) ]

6.  Other Pre-specified:   The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 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 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 26, 52, 78 and 104.   [ 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 12, 26, 36, 52, 66, 78, 91 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
Since the study was early terminated and the data could not be obtained as planned, only part of the immunogenicity and safety results were summarized.


  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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01238991     History of Changes
Other Study ID Numbers: B2571001, 3134K1-2207
Study First Received: October 21, 2010
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration