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The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 priming doses followed by 4 boosters | Experimental | Subjects will receive 7 doses of UB-311. |
|
| 3 priming doses followed by 2 boosters | Experimental | Subjects will receive 5 doses of UB-311 and 2 doses of placebo. |
|
| Placebo | Placebo Comparator | Subjects will receive 7 doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-311 | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events | Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs. | 78 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital (KS-CGMH) | Kaohsiung City | Taiwan | ||||
| National Taiwan University Hospital (NTUH) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37392597 | Derived | Yu HJ, Dickson SP, Wang PN, Chiu MJ, Huang CC, Chang CC, Liu H, Hendrix SB, Dodart JC, Verma A, Wang CY, Cummings J. Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study. EBioMedicine. 2023 Aug;94:104665. doi: 10.1016/j.ebiom.2023.104665. Epub 2023 Jun 29. | |
| 29067332 |
| Label | URL |
|---|---|
| Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Priming Doses Followed by 4 Boosters | Subjects will receive 7 doses of UB-311. UB-311: Intramuscular injection |
| FG001 | 3 Priming Doses Followed by 2 Boosters | Subjects will receive 5 doses of UB-311 and 2 doses of placebo. UB-311: Intramuscular injection Placebo: Intramuscular injection |
| FG002 | Placebo | Subjects will receive 7 doses of placebo. Placebo: Intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 Priming Doses Followed by 4 Boosters | Subjects will receive 7 doses of UB-311. UB-311: Intramuscular injection |
| BG001 | 3 Priming Doses Followed by 2 Boosters | Subjects will receive 5 doses of UB-311 and 2 doses of placebo. UB-311: Intramuscular injection Placebo: Intramuscular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events | Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs. | Posted | Count of Participants | Participants | 78 weeks |
|
78 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Priming Doses Followed by 4 Boosters | Subjects will receive 7 doses of UB-311. UB-311: Intramuscular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Responsible Medical Officer | United Neuroscience | +(353) 1 524 0397 | info@unitedneuroscience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2017 | Dec 24, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Mar 4, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Drug | Intramuscular injection |
|
| Taipei |
| Taiwan |
| Taipei Veterans General Hospital (TVGH) | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital (LK-CGMH) | Taoyuan | Taiwan |
| Derived |
| Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun. |
| BG002 | Placebo | Subjects will receive 7 doses of placebo. Placebo: Intramuscular injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| APOE4 carrier | Count of Participants | Participants |
|
| OG002 | Placebo | Subjects will receive 7 doses of placebo. Placebo: Intramuscular injection |
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 4 |
| 14 |
| EG001 | 3 Priming Doses Followed by 2 Boosters | Subjects will receive 5 doses of UB-311 and 2 doses of placebo. UB-311: Intramuscular injection Placebo: Intramuscular injection | 0 | 15 | 3 | 15 | 6 | 15 |
| EG002 | Placebo | Subjects will receive 7 doses of placebo. Placebo: Intramuscular injection | 0 | 14 | 2 | 14 | 9 | 14 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | Systematic Assessment |
|
Site PIs must jointly publish results, unless permission is granted by Sponsor. If a joint publication is not done within 12 months after trial completion and database lock, then the site may publish its own results; provided that, a) Sponsor has 45 business days to review the proposed publication; b) the PI must delete any confidential information identified by Sponsor; and c) the PI must delay disclosure for 1 year if a patent application is filed by Sponsor.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |