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: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: ACC-001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results, including AEs, vital signs, weight, laboratory tests, ECGs MRI, physical and neurological examinations [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-a-beta IgG (Immunoglobin G) titer at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Anti-a-beta IGM (Immunoglobin M) titer at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Anti-a-beta IgG subtypes titer if applicable, at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Behavior) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of DAD (Disability Assessment for Dementia) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of NTB (Neuropsychiatric Test Battery) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of MMSE (Mini-Mental State Examination) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Biological: ACC-001
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
Experimental: ACC-001 (10 micrograms) + QS-21
Active vaccine dose of 10 micrograms +adjuvant, IM injection, 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
Experimental: ACC-001 (30 micrograms) + QS-21
Active vaccine dose of 30 micrograms +adjuvant, IM injection, 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

  Eligibility

Ages Eligible for Study:   52 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238991

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Kasama, Ibaraki, Japan
Pfizer Investigational Site
Atsugi, Kanagawa, Japan
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Suwa, Nagano, Japan
Pfizer Investigational Site
Takatsuki, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Osaka, Japan
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014