Clinical Trials List
Protocol NumberV203-AD-EXT
NCT Number(ClinicalTrials.gov Identfier)NCT03531710
2018-03-01 - 2019-12-31
Phase II
Terminated4
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
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Trial Applicant
United Neuroscience
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Sponsor
United Neuroscience Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳韋達 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- KuoLun Huang Division of Neurology
- Kun-Ju Lin Division of Nuclear Medicine
- Tzu-Chen Yen Division of Nuclear Medicine
- 杜振豐 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- TA-FU CHEN Division of Neurology
- YA-FANG CHEN Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Alzheimer's Disease
Objectives
The primary objectives of this study are to assess the long-term safety and tolerability of UB-311
treatment, and to evaluate the immunogenicity of UB-311 through measurement of anti-Aβ
antibodies.
The secondary objectives are to evaluate the effects of UB-311 on the changes of cognitive and
global performance and to investigate whether UB-311 treatment results in group differences and
changes in amyloid deposition in vivo evaluated by18F-AV-45 PET imaging. In addition, the change
of qEEG, brain volume/cortical thickness and level of neurodegenerative biomarkers in blood will
be assessed for AD progression and UB-311 efficacy evaluation.
Test Drug
UBITh AD Immunotherapeutic Vaccine (UB-311)
Active Ingredient
Aβ1-14
Dosage Form
injection
Dosage
300 μg/0.5 mL/vial
Endpoints
Primary
The primary endpoints of this study are:
Safety and tolerability of UB-311: incidence of adverse event (AE)/serious adverse event (SAE).
The immunogenicity of UB-311 as measured by
– Change in anti-Aβ antibody levels
– Response rate (see section 6.1.2 for definition)
Secondary
The secondary endpoints are to measure the treatment effects of UB-311 on:
The change in cognitive and global assessments, including:
Alzheimer‟s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Mini-Mental State Exam (MMSE)
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Computerized cognitive tests
The change from baseline of V203-AD study in amyloid deposition by 18F-AV-45 PET imaging;
The primary endpoints of this study are:
Safety and tolerability of UB-311: incidence of adverse event (AE)/serious adverse event (SAE).
The immunogenicity of UB-311 as measured by
– Change in anti-Aβ antibody levels
– Response rate (see section 6.1.2 for definition)
Secondary
The secondary endpoints are to measure the treatment effects of UB-311 on:
The change in cognitive and global assessments, including:
Alzheimer‟s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Mini-Mental State Exam (MMSE)
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Computerized cognitive tests
The change from baseline of V203-AD study in amyloid deposition by 18F-AV-45 PET imaging;
Inclution Criteria
Inclusion Criteria
For inclusion in the study subjects must fulfil all of the following criteria:
1. Patients who participated in V203-AD trial without major safety concerns;
2. The last UB-311/placebo injection received in V203-AD study should be at least 24 weeks
prior to the V1 of this extension study;
3. Stable doses of permitted medications for 3 months before screening, such as acetyl
cholinesterase (AChE) inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonist, ergot
alkaloids or their derivatives for cognitive enhancement;
4. Female must either be post-menopausal (no menstrual period for >1 year), surgically sterilized
or agree to avoid becoming pregnant during the entire period of this study; while sexually
active fertile male must agree to use effective birth control methods throughout the study
duration, if their sexual partner(s) are women of childbearing potential;
5. With a caregiver who has frequent contact with the subject (e.g. an average of 10 hours per
week or more) and agrees to sign the informed consent form (ICF) and to perform
study-related AD scales;
6. Both patient and his/her caregiver should sign the written informed consent before undergoing
any study procedures; and
7. Agree not to donate blood or blood products for transfusion during the study and for 3 months
thereafter.
For inclusion in the study subjects must fulfil all of the following criteria:
1. Patients who participated in V203-AD trial without major safety concerns;
2. The last UB-311/placebo injection received in V203-AD study should be at least 24 weeks
prior to the V1 of this extension study;
3. Stable doses of permitted medications for 3 months before screening, such as acetyl
cholinesterase (AChE) inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonist, ergot
alkaloids or their derivatives for cognitive enhancement;
4. Female must either be post-menopausal (no menstrual period for >1 year), surgically sterilized
or agree to avoid becoming pregnant during the entire period of this study; while sexually
active fertile male must agree to use effective birth control methods throughout the study
duration, if their sexual partner(s) are women of childbearing potential;
5. With a caregiver who has frequent contact with the subject (e.g. an average of 10 hours per
week or more) and agrees to sign the informed consent form (ICF) and to perform
study-related AD scales;
6. Both patient and his/her caregiver should sign the written informed consent before undergoing
any study procedures; and
7. Agree not to donate blood or blood products for transfusion during the study and for 3 months
thereafter.
Exclusion Criteria
Exclusion Criteria
Any of the following is regarded as a criterion for exclusion from the study:
1. Clinically significant neurological disease other than Alzheimer‟s disease, such as Parkinson‟s
disease, multi-infarct dementia, Huntington‟s disease, normal pressure hydrocephalus, brain
tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis,
or history of significant head trauma followed by persistent neurologic defaults or known
structural brain abnormalities;
2. Screening magnetic resonance imaging (MRI) scan with evidence of central nerves system
(CNS) infection, infarction, or other focal lesions, cerebrovascular disease, superficial
siderosis, macrohemorrhage, microhemorrhages, multiple lacunes or lacunes in a critical
memory structure accompanies with symptoms that the investigator determines to be a safety
concern;
3. Major depressive episode or manic episode as described in Diagnostic and Statistical Manual
of Mental Disorders, Fifth Edition (DSM-V) within the past 1 year before screening. Psychotic features, agitation or behavioural problems within the last 3 months before screening which
could lead to difficulty in complying with the protocol;
4. History of schizophrenia (DSM-V criteria);
5. Any significant systemic illness or unstable medical condition which could lead to difficulty in
complying with the protocol;
6. History of alcohol or substance abuse or dependence within the past 2 years before screening
(DSM-V criteria);
7. History of autoimmune disease, including but not limited to ankylosing spondylitis, Sjogren‟s
syndrome, systemic lupus erythematosus, rheumatic arthritis, or multiple sclerosis;
8. History of severe systemic disease that may affect a subject‟s participation at the investigator‟s
discretion;
9. History of anaphylaxis; other serious adverse reactions to any vaccine; or any serious allergic
reactions to medications requiring treatment;
10. Use of any prohibited medications within 4 weeks prior to screening;
11. Use of any investigational drug within 4 weeks before screening;
12. Previous exposure to any anti-A immunotherapy except UB-311;
13. History of cancer, including solid tumors and hematological malignancies (except basal cell
and in situ squamous cell carcinomas of the skin that have been excised and resolved);
14. Received blood or blood derivatives treatment within 3 months prior to screening; and
15. Current or recent participation (within 12 months before screening) in any procedures involving
radioactive agents such that radiation exposure of the subject in any given year would exceed
the whole-body limits of annual and total dose commitment of 5 rems set forth in the US Code
of Federal Regulations (CFR) Title 21 section 361.1.
16. Abnormal clinical laboratory values judged by the investigator to be a safety concern to join the
study
Any of the following is regarded as a criterion for exclusion from the study:
1. Clinically significant neurological disease other than Alzheimer‟s disease, such as Parkinson‟s
disease, multi-infarct dementia, Huntington‟s disease, normal pressure hydrocephalus, brain
tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis,
or history of significant head trauma followed by persistent neurologic defaults or known
structural brain abnormalities;
2. Screening magnetic resonance imaging (MRI) scan with evidence of central nerves system
(CNS) infection, infarction, or other focal lesions, cerebrovascular disease, superficial
siderosis, macrohemorrhage, microhemorrhages, multiple lacunes or lacunes in a critical
memory structure accompanies with symptoms that the investigator determines to be a safety
concern;
3. Major depressive episode or manic episode as described in Diagnostic and Statistical Manual
of Mental Disorders, Fifth Edition (DSM-V) within the past 1 year before screening. Psychotic features, agitation or behavioural problems within the last 3 months before screening which
could lead to difficulty in complying with the protocol;
4. History of schizophrenia (DSM-V criteria);
5. Any significant systemic illness or unstable medical condition which could lead to difficulty in
complying with the protocol;
6. History of alcohol or substance abuse or dependence within the past 2 years before screening
(DSM-V criteria);
7. History of autoimmune disease, including but not limited to ankylosing spondylitis, Sjogren‟s
syndrome, systemic lupus erythematosus, rheumatic arthritis, or multiple sclerosis;
8. History of severe systemic disease that may affect a subject‟s participation at the investigator‟s
discretion;
9. History of anaphylaxis; other serious adverse reactions to any vaccine; or any serious allergic
reactions to medications requiring treatment;
10. Use of any prohibited medications within 4 weeks prior to screening;
11. Use of any investigational drug within 4 weeks before screening;
12. Previous exposure to any anti-A immunotherapy except UB-311;
13. History of cancer, including solid tumors and hematological malignancies (except basal cell
and in situ squamous cell carcinomas of the skin that have been excised and resolved);
14. Received blood or blood derivatives treatment within 3 months prior to screening; and
15. Current or recent participation (within 12 months before screening) in any procedures involving
radioactive agents such that radiation exposure of the subject in any given year would exceed
the whole-body limits of annual and total dose commitment of 5 rems set forth in the US Code
of Federal Regulations (CFR) Title 21 section 361.1.
16. Abnormal clinical laboratory values judged by the investigator to be a safety concern to join the
study
The Estimated Number of Participants
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Taiwan
42 participants
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Global
42 participants
