Clinical trial NCT00498602: Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2007-07-10
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: To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's disease
* Age 50-85
* Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion Criteria:

* Significant Neurological Disease
* Major psychiatric disorder
* Clinically significant systemic illness Other exclusion criteria apply.

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
timeFrame: 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:
measure: 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
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
measure: 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
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Sun City
country: United States
facility: Banner Boswell Medical Center
state: Arizona
city: Sun City
country: United States
facility: 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: New Haven
country: United States
facility: General Clinical Research Center
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 Center
state: District of Columbia
city: Washington
country: United States
facility: GUMC
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 Women's Hospital
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: Barrnes-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: Edison
country: United States
facility: Pharmcare USA
state: New Jersey
city: New York
country: United States
facility: Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
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: The Memory Clinic
state: Vermont
city: Bennington
country: United States
facility: The Pharmacy
state: Vermont
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.