Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
- Conditions
- Alzheimer Disease
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Diagnosis of mild to moderate Alzheimer's disease
- Age 50-85
- Mini Mental State Examination (MMSE) 16-26 Other criteria apply
- Significant Neurological Disease
- Major psychiatric disorder
- Clinically significant systemic illness Other exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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)
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Banner Boswell Medical Center
🇺🇸Sun City, Arizona, United States
Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
General Clinical Research Center
🇺🇸Washington, District of Columbia, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
GUMC
🇺🇸Washington, District of Columbia, United States
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