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

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00955409
First received: August 4, 2009
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: ACC-001+ QS21
Drug: ACC-001
Drug: ACC-001 + QS21
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Long-Term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of ACC-001 With QS-21 Adjuvant In 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; clinically important changes in safety assessment results including adverse events , vital signs, weight, clinical laboratory tests, ECGs, MRI scans, and physical and neurological examinations. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline levels of anti-A-beta IgG, Anti-A-beta IgM and IgG subclass antibody levels at selected time points. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
ACC-001(3µg) + QS21
Drug: ACC-001+ QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
2
ACC-001(10µg) + QS21
Drug: ACC-001
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
3
ACC-001(30µg) + QS21
Drug: ACC-001 + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
  • Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score =10

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
  • Clinically significant systemic 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: NCT00955409

Locations
France
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Marseille cedex 5, France, 13385
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Pfizer Investigational Site
Toulouse cedex 9, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 14050
Pfizer Investigational Site
Bonn, Germany, 53127
Pfizer Investigational Site
Bonn, Germany, 48129
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Mannheim, Germany, 68159
Pfizer Investigational Site
Munich, Germany, 81675
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Barcelona, Spain, 08003
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: NCT00955409     History of Changes
Other Study ID Numbers: 3134K1-2203, B2571007
Study First Received: August 4, 2009
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

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
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014