Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
NCT ID: NCT02551809
Last Updated: 2020-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2015-10-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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3 priming doses followed by 4 boosters
Subjects will receive 7 doses of UB-311.
UB-311
Intramuscular injection
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311
Intramuscular injection
Placebo
Intramuscular injection
Placebo
Subjects will receive 7 doses of placebo.
Placebo
Intramuscular injection
Interventions
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UB-311
Intramuscular injection
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
* Clinical dementia rating (CDR) scores of 0.5 or 1
Exclusion Criteria
* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
60 Years
90 Years
ALL
No
Sponsors
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United Neuroscience Ltd.
INDUSTRY
Responsible Party
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Locations
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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 District, , Taiwan
Countries
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References
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Yu HJ, Dickson SP, Wang PN, Chiu MJ, Huang CC, Chang CC, Liu H, Hendrix SB, Dodart JC, Verma A, Wang CY, Cummings J. Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study. EBioMedicine. 2023 Aug;94:104665. doi: 10.1016/j.ebiom.2023.104665. Epub 2023 Jun 29.
Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.
Other Identifiers
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V203-AD
Identifier Type: -
Identifier Source: org_study_id
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