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

Phase 2

Terminated

• Conditions: Alzheimer Disease
• Interventions: Biological: ACC-001 (10 mcg) + QS-21; Biological: ACC-001+ QS21 (3mcg); Biological: ACC-001+QS-21 (30mcg)

• Registration Number: NCT00960531
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-12-18
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Results First Posted: 2016-04-01
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACC-001 (10mcg) + QS-21	ACC-001 (10 mcg) + QS-21	ACC-001 (10mcg) + QS-21
ACC-001 (3mcg) + QS-21	ACC-001+ QS21 (3mcg)	ACC-001 (3mcg) + QS-21
ACC-001 (30mcg) + QS-21	ACC-001+QS-21 (30mcg)	ACC-001 (30mcg) + QS-21

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (25)

Banner Boswell Medical Center; 🇺🇸 Sun City, Arizona, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Memory Enhancement Center of America, Inc.; 🇺🇸 Eatontown, New Jersey, United States

The Pharmacy, Inc; 🇺🇸 Bennington, Vermont, United States

General Clinical Research Unit; 🇺🇸 Washington, District of Columbia, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Palm Beach Neurology - Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

Columbia University/Taub Institute; 🇺🇸 New York, New York, United States

Barnes Jewish Hospital at Washington University; 🇺🇸 St. Louis, Missouri, United States

CUMC Research Pharmacy; 🇺🇸 New York, New York, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

The Memory Clinic; 🇺🇸 Bennington, Vermont, United States

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Southwestern Vermont Healthcare; 🇺🇸 Bennington, Vermont, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

Brigham and Woman's Hospital; 🇺🇸 Boston, Massachusetts, United States

Center for Alzheimer Research and Treatment; 🇺🇸 Boston, Massachusetts, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States