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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02531360 | Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies | EARLY_PHASE1 | COMPLETED | 7 | — | — | May 1, 2015 | Aug 1, 2016 | Dec 16, 2016 | 1 | United States |
The PET imaging outcome measure to evaluate tau burden will be the standardized uptake value (SUV), which will be calculated for the areas of interest by using the established methods for normalizing to subject weight and injected dose.
| Arm | Type | Description |
|---|---|---|
| [18F]MNI-815 (MNI-815) | EXPERIMENTAL | At the \[18F\]MNI-815 PET imaging visit, subjects will be injected with no more than 10mCi of \[18F\]MNI-815 |
| Name | Type | Description |
|---|---|---|
| [18F]MNI-815 (MNI-815) | DRUG | All enrolled subjects will undergo an \[18F\]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo \[18F\]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition. |
Inclusion Criteria: For all subjects: * Written informed consent must be obtained before any assessment is performed. * Female subjects must be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are chi...