The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Suwa Red Cross Hospital
Suwa, Nagano, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Meitetsu Hospital
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Time frame: Baseline up to 24 months
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.
Time frame: Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Time frame: Baseline up to 24 months
Anti-a-beta IgG Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Time frame: Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Geometric mean of anti-a-beta IgM titer from pre-study through Week 104
Time frame: Baseline up to 24 months
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IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
IM injection, Day 1, month 3, 6, 9, 12
Aichi, Japan
Ibaraki Prefectural Central Hospital
Ibaraki, Japan
Shonan Atsugi Hospital
Kanagawa, Japan
Kitasato University East Hospital
Kanagawa, Japan
Juntendo University Hospital
Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Japan
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, Japan