← Trials/Trial dossier/NCT03531710
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
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)
Lead sponsor
Asset
UB-311
Listed sites
4
Recruiting sites
-
Enrollment
34
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Study partner/caregiver required
Primary endpoints
•Adverse Event (AE /Serious Adverse Event (SAE [Safety and Tolerability]•Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
6 endpointsChange From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
ADAS-Cog
change from baseline, improvement
Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
ADAS-Cog
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| M7E1n=8 Participants | 2.86 | 4.811 |
| M7E3n=2 Participants | -0.50 | 2.121 |
| M5E1n=6 Participants | 2.50 | 4.324 |
| M5E3n=5 Participants | 5.67 | 3.512 |
| M0E1n=8 Participants | 3.50 | 3.564 |
| M0E3n=2 Participants | 1.00 | 1.414 |
Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| M7E1n=10 Participants | -1.80 | 3.225 |
| M7E3n=2 Participants | -1.50 | 2.121 |
| M5E1n=7 Participants | -0.57 | 1.618 |
| M5E3n=5 Participants | -3.00 | 4.183 |
| M0E1n=8 Participants | -4.38 | 4.868 |
| M0E3n=2 Participants | -2.00 | 2.828 |
Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| M7E1n=10 Participants | 1.50 | 2.483 |
| M7E3n=2 Participants | 0.00 | 0.000 |
| M5E1n=7 Participants | 0.64 | 1.345 |
| M5E3n=5 Participants | 2.00 | 3.082 |
| M0E1n=8 Participants | 3.69 | 4.869 |
| M0E3n=2 Participants | 0.75 | 1.061 |
Neuroimaging
2 endpointsThe Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
event count, event
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| M7E1n=10 Participants | 4 | - |
| M7E3n=2 Participants | 1 | - |
| M5E1n=7 Participants | 4 | - |
| M5E3n=5 Participants | 3 | - |
| M0E1n=8 Participants | 5 | - |
| M0E3n=2 Participants | 2 | - |
Safety / tolerability / PK
2 endpointsChange From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
change from baseline, event
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
Time frame:Overall Study Duration/Early Termination, over an average study duration of 326 days
change from baseline, event
Posted result
| Group | Value (geometric_mean), Geometric Mean Ratio in log10 | Standard deviation |
|---|---|---|
| M7E1n=10 Participants | 0.56 | 0.72 |
| M7E3n=2 Participants | 0.11 | 0.35 |
| M5E1n=7 Participants | 0.15 | 0.35 |
| M5E3n=5 Participants | 0.49 | 0.32 |
| M0E1n=8 Participants | 0.10 | 0.24 |
| M0E3n=2 Participants | 0.80 | 0.09 |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.