A Long Term Extension Study Evaluating ACC-001 With QS-21 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:
NCT00960531
First received: August 13, 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 vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
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. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: July 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 + QS-21
Drug: ACC-001+ QS21
IM injection, ACC-001(3mcg, or 10mcg, or 30mcg) + QS-21 50 mcg at Day 1 and weeks 26, 52, and 78

  Eligibility

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

Inclusion Criteria:

Subjects randomized under previous 3134K1-2201 study (NCT00498602) 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 greater than or equal to 10.

Other criteria apply.

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Other exclusion criteria apply.

  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: NCT00960531

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94158
Pfizer Investigational Site
San Francisco, California, United States, 94143
Pfizer Investigational Site
San Francisco, California, United States, 94117
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20057
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63108
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201
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: NCT00960531     History of Changes
Other Study ID Numbers: 3134K1-2205, B2571008
Study First Received: August 13, 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 October 19, 2014