Clinical trial NCT01227564: Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Official title: A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Early Alzheimer's disease
active immunization
amyloid imaging
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2010-10-25
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.


Eligibility criteria: Inclusion Criteria:

* Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
* Mini-Mental State Examination (MMSE) score ≥ 25
* Global Clinical Dementia Rating = 0.5.
* General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
* Amyloid burden detected on screening brain PET scan.
* Other inclusion criteria apply.

Exclusion Criteria:

* Significant neurological disease other than early Alzheimer's disease
* Major psychiatric disorder or symptom
* Contraindication to undergo brain MRI
* Unstable medical conditions
* Other exclusion criteria apply

Primary outcomes:
measure: Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
timeFrame: 104 weeks
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40
timeFrame: Week 80 or Week 104
measure: Change From Baseline in CSF Aβ x-42
timeFrame: Week 80 or Week 104
measure: Change From Baseline in CSF p-Tau
timeFrame: Week 80 or Week 104
measure: Change From Baseline in CSF Total Tau
timeFrame: Week 80 or Week 104
measure: Change From Baseline in Plasma Aβ x-40
timeFrame: 104 weeks
measure: Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)
timeFrame: 104 weeks
measure: Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)
timeFrame: 104 weeks
measure: Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total
timeFrame: 104 weeks
measure: Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left
timeFrame: 104 weeks
measure: Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right
timeFrame: 104 weeks
measure: Change From Baseline in Neuropsychological Test Battery (NTB)
timeFrame: 104 weeks
measure: Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score
timeFrame: 104 weeks
measure: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
timeFrame: 104 weeks
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
timeFrame: 104 weeks
measure: Change From Baseline in NPI Distress Score (NPI-D)
timeFrame: 104 weeks
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score
timeFrame: 104 weeks
measure: Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score
timeFrame: 104 weeks
measure: Change From Baseline in Dependence Scale (DS) Score
timeFrame: 104 weeks
measure: Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver
timeFrame: 104 weeks
measure: Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers
timeFrame: 104 weeks
measure: Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time
timeFrame: 104 weeks
measure: Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers
timeFrame: 104 weeks
measure: Geometric Mean Anti-Aβ IgM ELISA Titers
timeFrame: 104 weeks
measure: Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ - Subject - Prospective Memory Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ - Subject - Planning/Organization Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ - Subject - Total Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score
timeFrame: 104 weeks
measure: Change From Baseline in PDQ-R - Relative - Total Score
timeFrame: 104 weeks
measure: Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)
timeFrame: 104 weeks
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: Banner Lakes Imaging Center
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southwest PET Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona, Health Sciences Center - Department of Neurology
state: Arizona
city: Tucson
country: United States
facility: Universal Medical Center
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, LLC
state: Arizona
city: Tucson
country: United States
facility: Radiology Limited
state: Arizona
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: New Haven
country: United States
facility: GCRC (Drug administered)
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine, Alzheimer's Disease Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Investigational Drug Service
state: Connecticut
city: New Haven
country: United States
facility: Norman S. Werdiger, MD
state: Connecticut
city: Washington
country: United States
facility: Clinical Research Unit
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University Medical Center Department of Neurology
state: District of Columbia
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Florida Neurology Group PL
state: Florida
city: Fort Myers
country: United States
facility: Internal Medicine Associates of Lee County, MD, PA
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Fort Myers
country: United States
facility: Florida Radiology Leasing, Limited Liability Corporation
state: Florida
city: Fort Myers
country: United States
facility: Radiology Regional Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute (Palm Beach Neurology)
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital (For PET only)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Las Vegas
country: United States
facility: Steinberg Diagnostic Imaging
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Incorporated
state: New Jersey
city: Clifton Park
country: United States
facility: Satatoga PET Associates
state: New York
city: East Providence
country: United States
facility: Rhode Island Mood and Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Houston
country: United States
facility: Baylor College of Medicine, Department of Neurology
state: Texas
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:
citation: van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.