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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02551809
Enrollment
43
Registered
2015-09-16
Start date
2015-10-31
Completion date
2018-08-31
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

BIOLOGICALUB-311

Intramuscular injection

DRUGPlacebo

Intramuscular injection

Sponsors

United Neuroscience Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events78 weeksSafety 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.

Countries

Taiwan

Participant flow

Participants by arm

ArmCount
3 Priming Doses Followed by 4 Boosters
Subjects will receive 7 doses of UB-311. UB-311: Intramuscular injection
14
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
15
Placebo
Subjects will receive 7 doses of placebo. Placebo: Intramuscular injection
14
Total43

Baseline characteristics

Characteristic3 Priming Doses Followed by 4 BoostersTotalPlacebo3 Priming Doses Followed by 2 Boosters
Age, Continuous73.4 years
STANDARD_DEVIATION 6.81
72.6 years
STANDARD_DEVIATION 6.93
72.0 years
STANDARD_DEVIATION 7.62
72.5 years
STANDARD_DEVIATION 6.79
APOE4 carrier10 Participants35 Participants13 Participants12 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
14 Participants43 Participants14 Participants15 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
11 Participants32 Participants11 Participants10 Participants
Sex: Female, Male
Male
3 Participants11 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 150 / 14
other
Total, other adverse events
4 / 146 / 159 / 14
serious
Total, serious adverse events
1 / 143 / 152 / 14

Outcome results

Primary

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.

Time frame: 78 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
3 Priming Doses Followed by 4 BoostersTolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events10 Participants
3 Priming Doses Followed by 2 BoostersTolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events13 Participants
PlaceboTolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events13 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026