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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03748706 | PTI-125 for Mild-to-moderate Alzheimer's Disease Patients | PHASE2 | COMPLETED | 13 | — | — | Mar 7, 2019 | May 8, 2019 | Jul 7, 2021 | 2 | United States |
Blood draws will be done to evaluate levels of PTI-125 in the plasma using non-compartmental methods in WinNonlin.
Levels of PTI-125 will be assessed to determine how long it takes to reach the Cmax
Levels of PTI-125 will be assessed to determine the last time point where PTI-125 can be detected.
Levels of PTI-125 will be assessed to determine the elapsed time to where PTI-125 can last be detected in the plasma.
AUC for PTI-125 plasma concentration from time zero to the last quantifiable plasma concentration.
Assessment of the half-life in plasma of PTI-125
| Arm | Type | Description |
|---|---|---|
| Simufilam (PTI-125) | EXPERIMENTAL | Simufilam (PTI-125) 100 mg oral tablets administered twice daily (BID) |
| Name | Type | Description |
|---|---|---|
| PTI-125, 100 mg tablets | DRUG | PTI-125, 100 mg tablets taken twice a day for 28 days |
Inclusion Criteria: * Ages \>= 50 and \<= 85 years * Informed consent form (ICF) signed by the subject or legally acceptable representative. * Clinical diagnosis of dementia due to possible or probable Alzheimer's disease * Mini-Mental State Examination score \>= 16 and \<= 24 at screening * If fem...