To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
Kaohsiung City, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan
Taipei Veterans General Hospital (TVGH)
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital (LK-CGMH)
Taoyuan, Taiwan
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
Time frame: Overall Study Duration/Early Termination, over an average study duration of 326 days
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
Time frame: Overall Study Duration/Early Termination, over an average study duration of 326 days
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