Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Biological: ACC-001 + QS-21; Biological: QS-21; Biological: ACC-001

• Registration Number: NCT00498602
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Study Start: 2007-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-04-23
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-30
• Last Update Submitted: 2015-11-30
• Results First Posted: 2016-01-01
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of mild to moderate Alzheimer's disease
• Age 50-85
• Mini Mental State Examination (MMSE) 16-26 Other criteria apply

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Exclusion Criteria

• Significant Neurological Disease
• Major psychiatric disorder
• Clinically significant systemic illness Other exclusion criteria apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ACC-001 + QS-21	ACC-001
2	QS-21	QS-21
4	ACC-001	ACC-001

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose	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

Name	Time	Method
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	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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.
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)	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	IgG subtypes were not assessed
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	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.

Trial Locations

Locations (23)

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

Barrnes-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

Columbia Univ/Taub Institute Irving Ctr for Clinical Researc; 🇺🇸 New York, New York, United States

GUMC; 🇺🇸 Washington, District of Columbia, United States

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

Pharmcare USA; 🇺🇸 Edison, New Jersey, United States

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

Banner Good Samaritan Medical Center; 🇺🇸 Phoenix, Arizona, United States

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

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

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

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

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

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

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

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

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

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

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

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

The Pharmacy; 🇺🇸 Bennington, Vermont, United States