Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03577262 | A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density | EARLY_PHASE1 | COMPLETED | 19 | — | — | Jul 23, 2018 | Aug 2, 2019 | Feb 20, 2020 | 3 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| Healthy subjects [11C]-UCB-J | EXPERIMENTAL | Net dose of approximately 370 megabecquerel (MBq) of \[11C\]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28 |
| AD patients [11C]-UCB-J | EXPERIMENTAL | Net dose of approximately 370 megabecquerel (MBq) of \[11C\]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28 |
| Name | Type | Description |
|---|---|---|
| [11C]-UCB-J | OTHER | IV radioligand given prior to and during positron emission tomography (PET) scan |
Inclusion Criteria: Group 1 * Healthy male or female age 55 - 75 years old, inclusive, at the time of informed consent. * Mini-mental state examination (MMSE) greater than or equal to 27. Group 2 * Adult males or females age 55 - 75 years old, inclusive, at the time of informed consent. * Confir...