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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
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.
Time frame: 24 months
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Boswell Medical Center
Sun City, Arizona, United States
Banner 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
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
Yale New Haven Hospital
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
...and 18 more locations