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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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
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: May 14, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 67
Study Start Date: December 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238991

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Japan
Pfizer Investigational Site Active, not recruiting
Nagoya, Aichi, Japan
Pfizer Investigational Site Active, not recruiting
Kasama, Ibaraki, Japan
Pfizer Investigational Site Active, not recruiting
Atsugi, Kanagawa, Japan
Pfizer Investigational Site Recruiting
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site Active, not recruiting
Suwa, Nagano, Japan
Pfizer Investigational Site Active, not recruiting
Takatsuki, Osaka, Japan
Pfizer Investigational Site Active, not recruiting
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site Active, not recruiting
Koto-ku, Tokyo, Japan
Pfizer Investigational Site Active, not recruiting
Minato-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site Active, not recruiting
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: May 14, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 19, 2013