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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: November 30, 2015
Last verified: November 2015
  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 Alzheimers Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose ] [ Designated as safety issue: Yes ]
    An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.

  • 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 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.

  • 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) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    IgG subtypes were not assessed


Enrollment: 160
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   (Adult, Senior)
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
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: NCT00498602

Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Banner Boswell Medical Center
Sun City, Arizona, United States, 85351
Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
University of California - San Francisco
San Francisco, California, United States, 94117
University of California, San Francisco
San Francisco, California, United States, 94117
University of California, San Francisco
San Francisco, California, United States, 94118
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Connecticut
General Clinical Research Center
New Haven, Connecticut, United States, 06509
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06511
United States, District of Columbia
General Clinical Research Center
Washington, District of Columbia, United States, 20007
GUMC
Washington, District of Columbia, United States, 20057
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63108
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Barrnes-Jewish Hospital at Washington University
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Pharmcare USA
Edison, New Jersey, United States, 08837
United States, New York
Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
New York, New York, United States, 10032
CUMC Research Pharmacy
New York, New York, United States, 10032
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
The Pharmacy
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00498602     History of Changes
Other Study ID Numbers: 3134K1-2201  B2571005 
Study First Received: July 9, 2007
Results First Received: April 23, 2014
Last Updated: November 30, 2015
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
Neurocognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016