CClinicalTrials.gg
Sign In
CompletedNCT00965588Updated Aug 23, 2011

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

A Phase 1 interventional study of UB 311 in Alzheimer's Disease, sponsored by United Biomedical. Completed at 2 sites in Taiwan. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-08-23.

Sponsored by United Biomedical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

Browse trials for

Keywords

  • Alzheimer's disease
  • amyloid beta
  • vaccine
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 19 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

United Biomedical is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Major psychiatric disorder
  • Severe systemic disease
  • Serious adverse reactions to any vaccine
  • Other exclusion criteria apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Vaccine (UB 311)

    Biological: UB 311

Interventions

  • BiologicalUB 311

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

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

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

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

07

Study locations

2 sites
  • National Taiwan University Hospital (NTUH)
    Taipei, 10002, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
08

References and documents

Publications

  • Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19. PubMed 17287052 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00965588
Lead sponsor
United Biomedical
Collaborators
Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 25, 2009
Start date
Feb 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Aug 23, 2011

Study contacts

Ming-Jang Chiu, M.D.
principal investigator · National Taiwan University Hospital
Pei-Ning Wang, M.D.
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alzheimer Disease→

Other studies from this sponsor

United Biomedical

Start the discussion