Alzheimer's DiseaseNCT01189084
Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
An observational study of Alzheimer's Disease, run by United Biomedical at 2 sites in Taiwan.
Trial summary
The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Observational
- Type of treatment
- Vaccines
- How many people
- 14 participants
- Where
- 2 sitesTaiwan
- Study dates
- Apr 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol V118-AD) Phase I trial are eligible for continued follow-up to week 48
Who may be able to join
- Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial
Who cannot join
- Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital (NTUH)
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial
The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Observational
- Keywords
- Alzheimer's disease, amyloid beta, vaccine
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalBiological
Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).
| Study group | Role | What they receive |
|---|---|---|
| Observational immunotherapy follow-up | Not described Receives: Biological: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Long-term followup to week 48
Measured: 24 weeks
Secondary outcomes (1)
Efficacy
Long-term followup to week 48
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startApr 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pei-Ning Wang, M.D., Principal investigator, Taipei Veterans General Hospital (TVGH)Ming-Jang Chiu, M.D., Principal investigator, National Taiwan University Hospital (NTUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189084
- Sponsor's protocol ID
- UBI Protocol V118-obs
- Status last verified
- Jul 2011
- First submitted
- 24 Aug 2010
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial
- ClinicalTrials.gov ID
- NCT01189084
- Acronym / sponsor ID
- UBI Protocol V118-obs
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, amyloid beta, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- United BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital
- Study start
- Apr 2010
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational immunotherapy follow-up | – | Biological: Observational |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol V118-AD) Phase I trial are eligible for continued follow-up to week 48
Key inclusion criteria (1 listed)
- Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial
Key exclusion criteria (1 listed)
- Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalMeasure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment). | Biological | Observational immunotherapy follow-up |
Primary outcome
Immunogenicity
Time frame: 24 weeks
Long-term followup to week 48
1 secondary outcome
Efficacy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
- Background: PubMed 17287052Wang 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.
- ClinicalTrials.gov Identifier: NCT00965588Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Ning Wang, M.D. principal investigator
Taipei Veterans General Hospital (TVGH)
Ming-Jang Chiu, M.D. principal investigator
National Taiwan University Hospital (NTUH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by United Biomedical at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.