CompletedPhase 2Results posted

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

Lead sponsor

United Neuroscience Ltd.

Asset

UB-311

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26

Primary endpoint

•Tolerability and Safety Profile of UB-311 Assessed

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02551809

Org study IDV203-AD

Timeline

Milestones

Study first posted2015-09-16estimated

Study start2015-10actual (month precision)

Primary completion2018-08actual (month precision)

Study completion2018-08actual (month precision)

Results first posted2020-01-13actual

Last update posted2020-03-17actual

Assets

Drug assets

UB-311

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

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

Time frame:78 weeks

event count, event

Primary/registry result

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

Time frame:78 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
3 Priming Doses Followed by 4 Boostersn=14 Participants	10	-
3 Priming Doses Followed by 2 Boostersn=15 Participants	13	-
Placebon=14 Participants	13	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.