The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Meitetsu Hospital
Nagoya, Aichi-ken, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, Japan
Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan
Number of Treatment Emergent Adverse Events (AEs) by Severity
Number of mild, moderate, and 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 radiologists.
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 Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
Time frame: Baseline of the preceding studies through 24 months of this study
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Kitasato University East Hospital
Sagamihara-shi, Kanagawa, Japan
Suwa Red Cross Hospital
Suwa, Nagano, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, Japan
The Tokyo Jikei University School of Medicine
Minato-ku, Tokyo, Japan
...and 1 more locations