NCT02551809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

September 10, 2015

Results QC Date

December 24, 2019

Last Update Submit

March 4, 2020

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events

    Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.

    78 weeks

Study Arms (3)

3 priming doses followed by 4 boosters

EXPERIMENTAL

Subjects will receive 7 doses of UB-311.

Biological: UB-311

3 priming doses followed by 2 boosters

EXPERIMENTAL

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

Biological: UB-311Drug: Placebo

Placebo

PLACEBO COMPARATOR

Subjects will receive 7 doses of placebo.

Drug: Placebo

Interventions

UB-311BIOLOGICAL

Intramuscular injection

3 priming doses followed by 2 boosters3 priming doses followed by 4 boosters
PlaceboDRUG

Intramuscular injection

3 priming doses followed by 2 boostersPlacebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinically significant neurological disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Severe systemic disease
  • Serious adverse reactions to any vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Location

Taipei Veterans General Hospital (TVGH)

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital (LK-CGMH)

Taoyuan District, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 37392597DERIVED

  • 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.

    PMID: 29067332DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Responsible Medical Officer
Organization
United Neuroscience
info@unitedneuroscience.com
+(353) 1 524 0397

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 16, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 17, 2020

Results First Posted

January 13, 2020

Record last verified: 2020-03

Locations

TW(4)