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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| National Taiwan University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational immunotherapy follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Biological | Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Long-term followup to week 48 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Long-term followup to week 48 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pei-Ning Wang, M.D. | Taipei Veterans General Hospital (TVGH) | Principal Investigator |
| Ming-Jang Chiu, M.D. | National Taiwan University Hospital (NTUH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital (NTUH) | Taipei | 10002 | Taiwan | |||
| Taipei Veterans General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17287052 | Background | 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. |
| Label | URL |
|---|---|
| ClinicalTrials.gov Identifier: NCT00965588 | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody levels.
| Taipei |
| 11217 |
| Taiwan |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |