The goal of this clinical trial is to evaluate safety and potential therapeutic effect of intraveneously administered CB-AC-02 in patients with Alzheimer's Disease.
Subjects will receive either the single or multiple doses of CB-AC-02 to be followed up and evaluated for safety and potential therapeutic effect
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Stage1: ① Group1: CB-AC-02 administration on day 0 ② Group2: CB-AC-02 administration on day 0 and on week 4 (repeated injection) Stage2 ① Arm1: K-MMSE 20\~26 CB-AC-02 administration on day 0 and on week 4 (repeated injection) ② Arm2: K-MMSE 10\~19 CB-AC-02 administration on day 0 and on week 4 (repeated injection)
Stage2: Placebo administration on day 0 and on week 4 (repeated injection)
Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Number of Adverse Events
Number of subjects with treatment-related adverse events. The safety and tolerability of treatment with CB-AC-02 will be assessed by analysis of adverse events, abnormal findings on physical examinations, standard laboratory tests.
Time frame: 48 weeks
Changes from the baseline in K-MMSE Score
K-MMSE, Korean-Mini Mental Status Examination
Time frame: 48 weeks
Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging
CMRglc, cerebral metabolic rate for glucose
Time frame: 48 weeks
Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging
SPM, statistical parametric mapping
Time frame: 48 weeks
Changes of band power in qEEG
qEEG, Quantitative electroencephalography
Time frame: 48 weeks
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