Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimers Disease
2 other identifiers
interventional
160
1 country
27
Brief Summary
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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 Nov 2007
Longer than P75 for phase_2 alzheimer-disease
27 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
First Submitted
Initial submission to the registry
July 9, 2007
CompletedFirst Posted
Study publicly available on registry
July 10, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
January 1, 2016
CompletedJanuary 1, 2016
November 1, 2015
5.3 years
July 9, 2007
April 23, 2014
November 30, 2015
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.
approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose
Secondary Outcomes (3)
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Study Arms (4)
1
EXPERIMENTALACC-001
2
OTHERQS-21
3
OTHERDiluent: Phosphate Buffered Saline
4
EXPERIMENTALACC-001
Interventions
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate Alzheimer's disease
- Age 50-85
- Mini Mental State Examination (MMSE) 16-26 Other criteria apply
You may not qualify if:
- Significant Neurological Disease
- Major psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Banner Boswell Medical Center
Sun City, Arizona, 85351, United States
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, 94118, United States
University of California, San Francisco
San Francisco, California, 94158, United States
General Clinical Research Center
New Haven, Connecticut, 06509, 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 Center
Washington D.C., District of Columbia, 20007, United States
GUMC
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 Women's Hospital
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
Barrnes-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
Pharmcare USA
Edison, New Jersey, 08837, United States
Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
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
The Memory Clinic
Bennington, Vermont, 05201, United States
The Pharmacy
Bennington, Vermont, 05201, United States
Related Publications (1)
Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
PMID: 26967206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
July 9, 2007
First Posted
July 10, 2007
Study Start
November 1, 2007
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11