Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01227564
First received: October 22, 2010
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: ACC-001 3 μg/ QS-21 50 μg
Biological: ACC-001 10 μg/ QS-21 50 μg
Other: Placebo- Phosphate buffered saline (PBS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Explore the capacity of 2 dosage levels of ACC-001 plus QS-21 to remove brain fibrillar Aβ in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in disease biomarkers. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in measurements of immunogenicity. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in cognitive and functional scales. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in health outcome measures. [ Time Frame: study duration ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC-001 3 μg/ QS-21 50 μg Biological: ACC-001 3 μg/ QS-21 50 μg
ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
Other Name: Vanutide Cridificar
Experimental: ACC-001 10 μg/ QS-21 50 μg Biological: ACC-001 10 μg/ QS-21 50 μg
ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
Other Name: Vanutide Cridificar
Placebo Comparator: Placebo- Phosphate buffered saline (PBS) Other: Placebo- Phosphate buffered saline (PBS)
Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227564

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
Pfizer Investigational Site
Sun City, Arizona, United States, 85372
Pfizer Investigational Site
Tucson, Arizona, United States, 85719
Pfizer Investigational Site
Tucson, Arizona, United States, 85724
Pfizer Investigational Site
Tucson, Arizona, United States, 85724-5023
Pfizer Investigational Site
Tucson, Arizona, United States, 85741
Pfizer Investigational Site
Tucson, Arizona, United States, 85741-3537
United States, California
Pfizer Investigational Site
Oxnard, California, United States, 93030
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20057
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Pfizer Investigational Site
Brooksville, Florida, United States, 34601
Pfizer Investigational Site
Fort Myers, Florida, United States, 33919
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
Pfizer Investigational Site
Fort Myers, Florida, United States, 33907
Pfizer Investigational Site
Miami, Florida, United States, 33137
Pfizer Investigational Site
Miami Beach, Florida, United States, 33140
Pfizer Investigational Site
Wellington, Florida, United States, 33449
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68105
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89135
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
United States, New York
Pfizer Investigational Site
Clifton Park, New York, United States, 12065
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01227564     History of Changes
Other Study ID Numbers: B2571010, B2571010
Study First Received: October 22, 2010
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Early Alzheimer's disease
active immunization
amyloid imaging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014