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Study Evaluating ACC-001 In Subjects With Mild To Moderate 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:
NCT00498602
First received: July 9, 2007
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
 Biological: ACC-001 + QS-21
Biological: QS-21
Other: Diluent: Phosphate Buffered Saline
Biological: ACC-001
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The incidence and severity of treatment-emergent adverse events (TEAEs). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the immunogenicity of each dose level of ACC-001 with or without QS-21 in subjects with mild to moderate AD. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change from baseline blood levels of anti A-beta immunoglobulin G (IgG) and immunoglobulin M (IgM) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: November 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACC-001
 Biological: ACC-001 + QS-21
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
2
QS-21
 Biological: QS-21
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
3
Diluent: Phosphate Buffered Saline
 Other: Diluent: Phosphate Buffered Saline
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
Experimental: 4
ACC-001
 Biological: ACC-001
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498602

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94117
Pfizer Investigational Site
San Francisco, California, United States, 94158
Pfizer Investigational Site
San Francisco, California, United States, 94118
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06509
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63108
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
Pfizer Investigational Site
Edison, New Jersey, United States, 08837
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00498602     History of Changes
Other Study ID Numbers: 3134K1-2201, B2571005
Study First Received: July 9, 2007
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

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 May 22, 2013