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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

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Meitetsu Hospital
Nagoya, Aichi, 451-8511 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

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

- 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.

NCT01238991
Pfizer
Terminated
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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Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
53
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
52 Years to 87 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01238991
B2571001
3134K1-2207 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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