Not provided
Not provided
Not provided
Not provided
Not provided
United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 boosters | Experimental | Subjects will receive 3 doses of UB-311 and 2 doses of placebo. |
|
| 3 priming doses followed by 2 boosters | Experimental | Subjects will receive 5 doses of UB-311. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-311 | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]). | Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests. | Overall Study Duration/Early Termination, over an average study duration of 326 days |
| Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311] | For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period. | Overall Study Duration/Early Termination, over an average study duration of 326 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog); | The ADAS-Cog 13 contains 13 items, with a total scoring range of 0 - 85 and higher scores indicating greater dysfunction. ADAS-Cog scores were evaluated at V1 and V8/ET. The observed values and change from baseline for ADAS-Cog scores by treatment groups in the extension study are presented |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital (KS-CGMH) | Kaohsiung City | Taiwan | ||||
| National Taiwan University Hospital (NTUH) |
Not provided
| Label | URL |
|---|---|
| Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. | View source |
| UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | M7E1 | Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| FG001 | M7E3 | Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| FG002 | M5E1 | Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| FG003 | M5E3 | Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| FG004 | M0E1 | Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| FG005 | M0E3 | Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | M7E1 | Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| BG001 | M7E3 | Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| 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 | The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]). | Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests. | Posted | Count of Participants | Participants | Overall Study Duration/Early Termination, over an average study duration of 326 days |
|
Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M7E1 | Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escherichia sepsis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
1. Due to the incorrect treatment assignment and study early termination, this study was underpowered for analysis with secondary endpoints. Therefore, all secondary endpoints (change in ADAS-Cog, MMSE, CDR-SB) were considered as exploratory efficacy endpoints. 2. qEEG, cortical thickness, computerized cognitive tests, and the change of amyloid deposition with substantial amount of missing data/visit so they were omitted from group comparison analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | United Neuroscience | +1 (972) 809-0481 | info@unitedneuroscience.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2018 | Jun 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2020 | Jun 1, 2020 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intramuscular injection |
|
| Overall Study Duration/Early Termination, over an average study duration of 326 days |
| Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE) | The MMSE is a 30-point questionnaire. The total score range is 0 - 30 and lower scores indicating greater impairment. MMSE scores were evaluated at V1 and V8/ET. The observed values and change from baseline for MMSE scores by treatment groups in the extension study are presented | Overall Study Duration/Early Termination, over an average study duration of 326 days |
| Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | The CDR-SB includes 6 domains (0 - 3 points/domain), with a total scoring range of 0 - 18 and higher scores indicate greater impartment. CDR-SB scores were evaluated at V1 and V8/ET. The observed values and change from baseline for CDR-SB scores by treatment groups in the extension study are presented | Overall Study Duration/Early Termination, over an average study duration of 326 days |
| Taipei |
| Taiwan |
| Taipei Veterans General Hospital (TVGH) | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital (LK-CGMH) | Taoyuan | Taiwan |
| BG002 | M5E1 | Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| BG003 | M5E3 | Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| BG004 | M0E1 | Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| BG005 | M0E3 | Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mini-Mental State Examination | MMSE Total Score Presented. The MMSE is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment and is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document a participant's response to treatment. The total score range is 0 - 30 and lower scores indicating greater impairment. | Mean | Standard Deviation | units on a scale |
|
| OG002 | M5E1 | Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| OG003 | M5E3 | Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3) |
| OG004 | M0E1 | Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) |
| OG005 | M0E3 | Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3) |
|
|
| Primary | Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311] | For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period. | Posted | Geometric Mean | Standard Deviation | Geometric Mean Ratio in log10 | Overall Study Duration/Early Termination, over an average study duration of 326 days |
|
|
|
| Other Pre-specified | Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog); | The ADAS-Cog 13 contains 13 items, with a total scoring range of 0 - 85 and higher scores indicating greater dysfunction. ADAS-Cog scores were evaluated at V1 and V8/ET. The observed values and change from baseline for ADAS-Cog scores by treatment groups in the extension study are presented | If more than one of 13 items of ADAS-Cog were missing/not available, ADASCog-13 total score was set to missing. | Posted | Mean | Standard Deviation | score on a scale | Overall Study Duration/Early Termination, over an average study duration of 326 days |
|
|
|
| Other Pre-specified | Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE) | The MMSE is a 30-point questionnaire. The total score range is 0 - 30 and lower scores indicating greater impairment. MMSE scores were evaluated at V1 and V8/ET. The observed values and change from baseline for MMSE scores by treatment groups in the extension study are presented | Posted | Mean | Standard Deviation | score on a scale | Overall Study Duration/Early Termination, over an average study duration of 326 days |
|
|
|
| Other Pre-specified | Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | The CDR-SB includes 6 domains (0 - 3 points/domain), with a total scoring range of 0 - 18 and higher scores indicate greater impartment. CDR-SB scores were evaluated at V1 and V8/ET. The observed values and change from baseline for CDR-SB scores by treatment groups in the extension study are presented | Posted | Mean | Standard Deviation | score on a scale | Overall Study Duration/Early Termination, over an average study duration of 326 days |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| 4 |
| 10 |
| EG001 | M7E3 | Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3) | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | M5E1 | Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) | 0 | 7 | 2 | 7 | 2 | 7 |
| EG003 | M5E3 | Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3) | 0 | 5 | 0 | 5 | 3 | 5 |
| EG004 | M0E1 | Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1) | 0 | 8 | 1 | 8 | 5 | 8 |
| EG005 | M0E3 | Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3) | 0 | 2 | 1 | 2 | 1 | 2 |
| Femoral neck fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Hemorrhagic transformation stroke | Nervous system disorders | Non-systematic Assessment |
|
| Purpura nonthrombocytopenic | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | Non-systematic Assessment |
|
| Vaccination site pain | General disorders | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | Non-systematic Assessment |
|
| Accident at home | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Inflammatory marker increased | Investigations | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-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 |