Clinical trial NCT00960531: A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2009-08-17
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
measure: 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)
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
measure: 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
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Boswell Medical Center
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: General Clinical Research Unit
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology - Premiere Research Institute
state: Florida
city: Boston
country: United States
facility: Brigham and Woman's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Center for Alzheimer Research and Treatment
state: Massachusetts
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital at Washington University
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: New York
country: United States
facility: Columbia University/Taub Institute
state: New York
city: New York
country: United States
facility: CUMC Research Pharmacy
state: New York
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Bennington
country: United States
facility: Southwestern Vermont Healthcare
state: Vermont
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Bennington
country: United States
facility: The Pharmacy, Inc
state: Vermont
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: