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CompletedPhase 1

Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

United Biomedical

Asset

UB-311

Listed sites

2

Recruiting sites

-

Enrollment

19

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 15-25

Primary endpoint

•Safety and tolerability of the vaccine (UB 311)

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 IDNCT00965588
SecondaryProtocol V118-AD
Org study IDUBI Protocol V118

Timeline

Milestones

Study start2009-02 (month precision)
Study first posted2009-08-25estimated
Primary completion2011-04actual (month precision)
Study completion2011-04actual (month precision)
Last update posted2011-08-23estimated

Assets

Drug assets

UB-311

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of mild to moderate Alzheimer's Disease
•Mini-Mental State Examination (MMSE) 15-25
•Other inclusion criteria apply

Exclusion criteria

•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.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

To evaluate safety and tolerability of the vaccine (UB 311).

Time frame:Screen, treatment & follow-up: 28-30 weeks

descriptive

Secondary/protocol endpoint

To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).

Time frame:Screen, treatment & follow-up: 28-30 weeks

descriptive

Publications (1)

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 tableno registry results posted yet

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.