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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00965588

Enrollment

Registered

2009-08-25

Start date

2009-02-28

Completion date

2011-04-30

Last updated

2011-08-23

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, amyloid beta, vaccine

Brief summary

The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Interventions

BIOLOGICALUB 311

Single liquid dose by intramuscular route at weeks 0, 4, 12.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate safety and tolerability of the vaccine (UB 311).	Screen, treatment & follow-up: 28-30 weeks

Secondary

Measure	Time frame
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).	Screen, treatment & follow-up: 28-30 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026