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A Long Term Extension Study Evaluating ACC-001 With QS-21 in 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:
NCT00960531
First received: August 13, 2009
Last updated: March 2, 2016
Last verified: March 2016
  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
Biological: ACC-001+ QS21 (3mcg)
Biological: ACC-001 (10 mcg) + QS-21
Biological: ACC-001+QS-21 (30mcg)
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 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Other Outcome Measures:
  • GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: No ]
    IgM was not statistically analyzed.

  • Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable) [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: No ]
    IgG subtypes were not assessed

  • Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: Yes ]
    The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.


Enrollment: 160
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
Experimental: ACC-001 (3mcg) + QS-21
ACC-001 (3mcg) + QS-21
Biological: ACC-001+ QS21 (3mcg)
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Experimental: ACC-001 (10mcg) + QS-21
ACC-001 (10mcg) + QS-21
Biological: ACC-001 (10 mcg) + QS-21
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Experimental: ACC-001 (30mcg) + QS-21
ACC-001 (30mcg) + QS-21
Biological: ACC-001+QS-21 (30mcg)
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Banner Boswell Medical Center
Sun City, Arizona, United States, 85351
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
University of California San Francisco
San Francisco, California, United States, 94117
University of California, San Francisco
San Francisco, California, United States, 94117
University of California - San Francisco
San Francisco, California, United States, 94143
University of California San Francisco
San Francisco, California, United States, 94158
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06511
United States, District of Columbia
General Clinical Research Unit
Washington, District of Columbia, United States, 20007
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
Center for Alzheimer Research and Treatment
Boston, Massachusetts, United States, 02115
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63108
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Barnes Jewish Hospital at Washington University
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
United States, New York
Columbia University/Taub Institute
New York, New York, United States, 10032
CUMC Research Pharmacy
New York, New York, United States, 10032
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Vermont
Southwestern Vermont Healthcare
Bennington, Vermont, United States, 05201
The Memory Clinic
Bennington, Vermont, United States, 05201
The Pharmacy, Inc
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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00960531     History of Changes
Other Study ID Numbers: 3134K1-2205  B2571008 
Study First Received: August 13, 2009
Results First Received: December 18, 2014
Last Updated: March 2, 2016
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
Neurocognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016