search
Back to results

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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACC-001+ QS21 (3mcg)
ACC-001 (10 mcg) + QS-21
ACC-001+QS-21 (30mcg)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner Alzheimer's Institute
  • Banner Boswell Medical Center
  • Banner Sun Health Research Institute
  • University of California San Francisco
  • University of California, San Francisco
  • University of California - San Francisco
  • University of California San Francisco
  • University of California, San Francisco
  • Yale New Haven Hospital
  • Yale University School of Medicine
  • Yale-New Haven Hospital
  • General Clinical Research Unit
  • Georgetown University Medical Center
  • MD Clinical
  • Palm Beach Neurology - Premiere Research Institute
  • Brigham and Woman's Hospital
  • Center for Alzheimer Research and Treatment
  • Barnes Jewish Hospital
  • Washington University School of Medicine
  • Barnes Jewish Hospital at Washington University
  • Washington University School of Medicine
  • Memory Enhancement Center of America, Inc.
  • Columbia University/Taub Institute
  • CUMC Research Pharmacy
  • Butler Hospital
  • Southwestern Vermont Healthcare
  • The Memory Clinic
  • The Pharmacy, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ACC-001 (3mcg) + QS-21

ACC-001 (10mcg) + QS-21

ACC-001 (30mcg) + QS-21

Arm Description

ACC-001 (3mcg) + QS-21

ACC-001 (10mcg) + QS-21

ACC-001 (30mcg) + QS-21

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
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

Full Information

First Posted
August 13, 2009
Last Updated
March 2, 2016
Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00960531
Brief Title
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACC-001 (3mcg) + QS-21
Arm Type
Experimental
Arm Description
ACC-001 (3mcg) + QS-21
Arm Title
ACC-001 (10mcg) + QS-21
Arm Type
Experimental
Arm Description
ACC-001 (10mcg) + QS-21
Arm Title
ACC-001 (30mcg) + QS-21
Arm Type
Experimental
Arm Description
ACC-001 (30mcg) + QS-21
Intervention Type
Biological
Intervention Name(s)
ACC-001+ QS21 (3mcg)
Intervention Description
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Intervention Type
Biological
Intervention Name(s)
ACC-001 (10 mcg) + QS-21
Intervention Description
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Intervention Type
Biological
Intervention Name(s)
ACC-001+QS-21 (30mcg)
Intervention Description
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Description
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.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
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
Description
IgM was not statistically analyzed.
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Title
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)
Description
IgG subtypes were not assessed
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Title
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
Description
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.
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Banner Boswell Medical Center
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
General Clinical Research Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Palm Beach Neurology - Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Brigham and Woman's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Alzheimer Research and Treatment
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Barnes Jewish Hospital at Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Columbia University/Taub Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CUMC Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Southwestern Vermont Healthcare
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
The Pharmacy, Inc
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-2205&StudyName=A%20Long%20Term%20Extension%20Study%20Evaluating%20ACC-001%20with%20QS-21%20in%20Subjects%20with%20Mild%20to%20Moderate%20Alzheimer%27s%20disease
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs