A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

March 2, 2016 updated by: Pfizer

A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
      • Sun City, Arizona, United States, 85351
        • Banner Boswell Medical Center
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
      • San Francisco, California, United States, 94158
        • 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
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
      • New Haven, Connecticut, United States, 06511
        • Yale-New Haven Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center
      • Washington, District of Columbia, United States, 20007
        • General Clinical Research Unit
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology - Premiere Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Woman's Hospital
      • Boston, Massachusetts, United States, 02115
        • Center for Alzheimer Research and Treatment
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, United States, 63108
        • Washington University School of Medicine
      • St. Louis, Missouri, United States, 63108
        • Barnes Jewish Hospital
      • St. Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital at Washington University
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc.
    • New York
      • New York, New York, United States, 10032
        • CUMC Research Pharmacy
      • New York, New York, United States, 10032
        • Columbia University/Taub Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Healthcare
      • Bennington, Vermont, United States, 05201
        • The Pharmacy, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.

Screening brain MRI scan is consistent with the diagnosis of AD.

Mini-Mental State Examination (MMSE) score greater than or equal to 10.

Other criteria apply.

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Other exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACC-001 (3mcg) + QS-21
Biological: ACC-001+ QS21 (3mcg)
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Experimental: ACC-001 (10mcg) + QS-21
Biological: ACC-001 (10 mcg) + QS-21
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Experimental: ACC-001 (30mcg) + QS-21
Biological: ACC-001+QS-21 (30mcg)
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Time Frame: 24 months
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.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)
Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
IgG subtypes were not assessed
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
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.
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
IgM was not statistically analyzed.
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3134K1-2205
  • B2571008 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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