A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
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
2 other identifiers
interventional
160
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 alzheimer-disease
Started Jul 2009
Longer than P75 for phase_2 alzheimer-disease
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 1, 2016
CompletedApril 1, 2016
March 1, 2016
4.4 years
August 13, 2009
December 18, 2014
March 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
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.
24 months
Other Outcomes (3)
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
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
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)
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
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
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Study Arms (3)
ACC-001 (3mcg) + QS-21
EXPERIMENTALACC-001 (3mcg) + QS-21
ACC-001 (10mcg) + QS-21
EXPERIMENTALACC-001 (10mcg) + QS-21
ACC-001 (30mcg) + QS-21
EXPERIMENTALACC-001 (30mcg) + QS-21
Interventions
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Eligibility Criteria
You may not qualify if:
- 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.
- Significant Neurological Disease other than Alzheimer's disease.
- Current clinically significant systemic illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Boswell Medical Center
Sun City, Arizona, 85351, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of California San Francisco
San Francisco, California, 94117, United States
University of California, San Francisco
San Francisco, California, 94117, United States
University of California - San Francisco
San Francisco, California, 94143, United States
University of California San Francisco
San Francisco, California, 94158, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06511, United States
General Clinical Research Unit
Washington D.C., District of Columbia, 20007, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
MD Clinical
Hallandale, Florida, 33009, United States
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Brigham and Woman's Hospital
Boston, Massachusetts, 02115, United States
Center for Alzheimer Research and Treatment
Boston, Massachusetts, 02115, United States
Barnes Jewish Hospital
St Louis, Missouri, 63108, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Barnes Jewish Hospital at Washington University
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Columbia University/Taub Institute
New York, New York, 10032, United States
CUMC Research Pharmacy
New York, New York, 10032, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Southwestern Vermont Healthcare
Bennington, Vermont, 05201, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
The Pharmacy, Inc
Bennington, Vermont, 05201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In 2013 the sponsor decided that ACC-001 would not be further developed in mild to moderate Alzheimer's disease, study drug administration was discontinued, and remaining participants were followed for safety for up to 6 months after last injection.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 17, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 1, 2016
Results First Posted
April 1, 2016
Record last verified: 2016-03