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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.

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE September 16, 2015
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • Tolerability and safety profile of UB-311 assessed via recording of all Adverse Events. [ Time Frame: 78 weeks ]
  • Immunogenicity of UB-311 measured by change from baseline in anti-Aβ antibody level [ Time Frame: 78 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02551809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Change from baseline in cognitive: Alzheimer´s Disease Assessment Scale- Cognitive (ADAS-Cog) [ Time Frame: 78 weeks ]
  • Change from baseline in function: Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: 78 weeks ]
  • Change from baseline in cognition: Mini-Mental State Examination (MMSE) [ Time Frame: 78 weeks ]
  • Change from baseline in global assessment: Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: 78 weeks ]
  • Change from baseline in behavioral assessment: Neuropsychiatric Inventory (NPI) [ Time Frame: 78 weeks ]
  • Change of amyloid burden from baseline in 18F-AV-45 PET imaging in selected brain areas [ Time Frame: 78 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • Change from baseline in cognitive: Alzheimer´s Disease Assessment Scale- Cognitive (ADAS-Cog) [ Time Frame: 78 weeks ]
  • Change from baseline in function: Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: 78 weeks ]
  • Change from baseline in cognition: Mini-Mental State Examination (MMSE) [ Time Frame: 78 weeks ]
  • Change from baseline in global assessment: Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: 78 weeks ]
  • Change from baseline in behavioral assessment: Neuropsychiatric Inventory (NPI) [ Time Frame: 78 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: UB-311
    Intramuscular injection
  • Drug: Placebo
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: 3 priming doses followed by 4 boosters
    Subjects will receive 7 doses of UB-311.
    Intervention: Biological: UB-311
  • Experimental: 3 priming doses followed by 2 boosters
    Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
    Interventions:
    • Biological: UB-311
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Subjects will receive 7 doses of placebo.
    Intervention: Drug: Placebo
Publications * 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(®) amyloid β 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2015)
45
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02551809
Other Study ID Numbers  ICMJE V203-AD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party United Neuroscience Ltd.
Study Sponsor  ICMJE United Neuroscience Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United Neuroscience Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP