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Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02551809
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
United Neuroscience Ltd.

Brief Summary:
The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease
Actual Study Start Date : October 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3 priming doses followed by 4 boosters
Subjects will receive 7 doses of UB-311.
Biological: UB-311
Intramuscular injection

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

Drug: Placebo
Intramuscular injection

Placebo Comparator: Placebo
Subjects will receive 7 doses of placebo.
Drug: Placebo
Intramuscular injection




Primary Outcome Measures :
  1. Tolerability and safety profile of UB-311 assessed via recording of all Adverse Events. [ Time Frame: 78 weeks ]
  2. Immunogenicity of UB-311 measured by change from baseline in anti-Aβ antibody level [ Time Frame: 78 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in cognitive: Alzheimer´s Disease Assessment Scale- Cognitive (ADAS-Cog) [ Time Frame: 78 weeks ]
  2. Change from baseline in function: Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: 78 weeks ]
  3. Change from baseline in cognition: Mini-Mental State Examination (MMSE) [ Time Frame: 78 weeks ]
  4. Change from baseline in global assessment: Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: 78 weeks ]
  5. Change from baseline in behavioral assessment: Neuropsychiatric Inventory (NPI) [ Time Frame: 78 weeks ]
  6. Change of amyloid burden from baseline in 18F-AV-45 PET imaging in selected brain areas [ Time Frame: 78 weeks ]


Information from the National Library of Medicine

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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:

  • Diagnosis of mild Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
  • Clinical dementia rating (CDR) scores of 0.5 or 1
  • 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

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): NCT02551809


Locations
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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.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: United Neuroscience Ltd.
ClinicalTrials.gov Identifier: NCT02551809     History of Changes
Other Study ID Numbers: V203-AD
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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

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