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

This study is currently recruiting participants.
Verified February 2014 by Pfizer
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: February 20, 2014
Last verified: February 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 ]

Estimated Enrollment: 63
Study Start Date: January 2011
Estimated Study Completion Date: February 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227564

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 35 Study Locations
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: February 20, 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 April 15, 2014