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

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NCT01238991

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Study Location
Meitetsu Hospital
Nagoya, Aichi, 451-8511, Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
52-87 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.

- Screening brain MRI scan is consistent with the diagnosis of AD.

- MMSE score 10 and above.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Significant neurological diseases other than AD.


- Brain MRI evidence of vasogenic edema during the preceding studies.


- Clinically significant illness.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Brief Summary The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: ACC-001
    IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
  • Biological: ACC-001
    IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
  • Biological: ACC-001
    IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
Study Arms  ICMJE
  • Experimental: ACC-001 (3 micrograms) + QS-21
    Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
  • Experimental: ACC-001 (10 micrograms) + QS-21
    Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
  • Experimental: ACC-001 (30 micrograms) + QS-21
    Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 6, 2014)		53
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2010)		67
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
  • Screening brain MRI scan is consistent with the diagnosis of AD.
  • MMSE score 10 and above.

Exclusion Criteria:

  • Significant neurological diseases other than AD.
  • Brain MRI evidence of vasogenic edema during the preceding studies.
  • Clinically significant illness.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 52 Years to 87 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01238991
Other Study ID Numbers  ICMJE B2571001
3134K1-2207 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP