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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05466422 | A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) | PHASE1 | COMPLETED | 34 | — | — | Sep 20, 2022 | Jul 3, 2025 | Aug 27, 2025 | 12 | United States |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
AUC is a measure of the extrapolated mean concentration in serum. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine AUC0-28 of MK-2214.
Cmax is the maximum concentration of the drug observed in plasma. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine Cmax of MK-2214.
Tmax is the amount of time required to reach Cmax. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine Tmax of MK-2214.
t1/2 is the time required for 50% of drug to be cleared from serum. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine t1/2 of MK-2214.
CSF concentration of MK-2214 will be presented for Day 85.
Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100\* free phospho-tau / baseline).
Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100\* free phospho-tau / baseline).
| Arm | Type | Description |
|---|---|---|
| MK-2214 | EXPERIMENTAL | Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as an IV infusion on Days 1, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| MK-2214 | BIOLOGICAL | MK-2214 in escalating doses as an IV infusion on Days 1, 29, and 57 |
| Placebo | DRUG | Placebo as an IV infusion on Days 1, 29, and 57 |
Inclusion Criteria: * Participant is in overall good health based on medical history and laboratory safety tests * BMI between 18.5 and 35 kg/m\^2 Part 1 (MCI and Mild to Moderate AD) Only: * History of cognitive and functional decline with gradual onset and slow progression for at least one year...