An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
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|ClinicalTrials.gov Identifier: NCT03531710|
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2018
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: UB-311 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)|
|Actual Study Start Date :||August 10, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: 3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Experimental: 3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311.
- The incidence of adverse event (AE)/serious adverse event (SAE) [Safety and Tolerability]). [ Time Frame: 108 weeks ]
- Change from baseline and through to the end of the study in anti-Aβ antibody titers [The immunogenicity of UB-311] [ Time Frame: 108 weeks ]
- Change from baseline in cognitive: Alzheimer´s Disease Assessment Scale- Cognitive [ Time Frame: 108 weeks ]
- Change from baseline in cognition: Mini-Mental State Examination [ Time Frame: 108 weeks ]
- Change from baseline in global assessment: Clinical Dementia Rating-Sum of Boxes [ Time Frame: 108 weeks ]
- Change from baseline in global assessment: Computerized cognitive test (Cogstate test battery) [ Time Frame: 108 weeks ]
- Change of amyloid deposition from baseline in 18F-AV-45 PET imaging in selected brain areas [ Time Frame: 108 weeks ]
- Change from baseline of brain volume assessed by vMRI [ Time Frame: 108 weeks ]
- The change from baseline of neurodegenerative biomarkers in blood [ Time Frame: 108 weeks ]The concentration of Amyloid beta 1-40, Amyloid beta 1-42, tau, neurofilament heavy chain (NFH), neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP) and ubiquitin C-Terminal Hydrolase L1 (UCHL1) in blood will be measured and compared with AD status.
- To evaluate the correlation between changes in qEEG and changes in cognition, if applicable [ Time Frame: 108 weeks ]The absolute and relative power spectral densities (PSDs) will be calculated and also grouped into the standard EEG bandwidths for comparison.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531710
|Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)|
|National Taiwan University Hospital (NTUH)|
|Taipei Veterans General Hospital (TVGH)|
|Linkou Chang Gung Memorial Hospital (LK-CGMH)|