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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
Sponsor:
Information provided by (Responsible Party):
United Neuroscience Ltd.

Study Description
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Brief Summary:
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: UB-311 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
 Biological: UB-311
Intramuscular injection

Drug: Placebo
Intramuscular injection
Experimental: 3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311.
 Biological: UB-311
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of adverse event (AE)/serious adverse event (SAE) [Safety and Tolerability]). [ Time Frame: 108 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Change from baseline in cognitive: Alzheimer´s Disease Assessment Scale- Cognitive [ Time Frame: 108 weeks ]
  2. Change from baseline in cognition: Mini-Mental State Examination [ Time Frame: 108 weeks ]
  3. Change from baseline in global assessment: Clinical Dementia Rating-Sum of Boxes [ Time Frame: 108 weeks ]
  4. Change from baseline in global assessment: Computerized cognitive test (Cogstate test battery) [ Time Frame: 108 weeks ]
  5. Change of amyloid deposition from baseline in 18F-AV-45 PET imaging in selected brain areas [ Time Frame: 108 weeks ]
  6. Change from baseline of brain volume assessed by vMRI [ Time Frame: 108 weeks ]
  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who participated in V203-AD trial without major safety concerns;
  • Stable doses of permitted medications for 3 months before screening;
  • With a caregiver;
  • Other inclusion criteria apply

Exclusion Criteria:

  • Clinically significant neurological disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Severe systemic disease
  • Serious adverse reactions to any vaccine
  • Other exclusion criteria apply
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
Kaohsiung, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan
Taipei Veterans General Hospital (TVGH)
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital (LK-CGMH)
Taoyuan, Taiwan
Sponsors and Collaborators
United Neuroscience Ltd.
More Information
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Additional Information:
Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.  This link exits the ClinicalTrials.gov site UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease.  This link exits the ClinicalTrials.gov site

Responsible Party: United Neuroscience Ltd.
ClinicalTrials.gov Identifier: NCT03531710     History of Changes
Other Study ID Numbers: V203-AD-EXT
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders