Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2214 · 2 trials · 2 indications
Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
An AE was 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 experienced at least one AE was reported.
An AE was 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 discontinued study treatment due to an AE was reported.
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after first dose (Day 1).
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after third dose (Day 57).
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after first dose (Day 1).
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after third dose (Day 57).
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after first dose (Day 1).
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after third dose (Day 57).
T1/2 was defined as the apparent half-life of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine t1/2 of MK-2214 in serum after third dose (Day 57).
Concentration of MK-2214 in CSF was defined as the CSF exposure of MK-2214. A CSF sample was to be collected on Day 85.
Concentration of free phospo-tau in CSF was defined as free phospho-tau levels in CSF after study treatment administration (MK-2214 or placebo). A CSF sample was to be collected on Day 85.
| Arm | Type | Description |
|---|---|---|
| MK-2214 | EXPERIMENTAL | Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a placebo via IV infusion q4w during the study. |
| Panel A: MK-2214 20 mg | EXPERIMENTAL | Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57). |
| Panel B: MK-2214 100 mg | EXPERIMENTAL | Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). |
| Panel C: MK-2214 500 mg | EXPERIMENTAL | Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). |
| Panel D: MK-2214 2000 mg | EXPERIMENTAL | Participants were randomized to receive MK-2214 2000 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). |
| Name | Type | Description |
|---|---|---|
| MK-2214 | BIOLOGICAL | IV infusion |
| Placebo | DRUG | IV infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) * Has a designated study partner who can fulfill the requirements of this study * If on an approved AD therapy for sy...
MK-2214 is an investigational monoclonal antibody being developed for Alzheimer's disease, including early Alzheimer's disease. It is being studied in adults with mild cognitive impairment or mild-to-moderate Alzheimer's disease, as well as in people with early Alzheimer's disease.
MK-2214 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential effects in Alzheimer's disease, though the exact mechanism of action is not publicly detailed.
MK-2214 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Alzheimer's disease.
MK-2214 is in Phase 2 clinical development. A Phase 1 study has been completed, and a Phase 2 trial is currently recruiting participants with early Alzheimer's disease. The drug is investigational and has not been approved by regulatory authorities.
MK-2214 has one completed Phase 1 trial, NCT05466422, which enrolled 34 participants with mild cognitive impairment or mild-to-moderate Alzheimer's disease in the United States. A Phase 2 trial, NCT07033494, is recruiting 340 participants with early Alzheimer's disease across multiple countries.
No alternative names for MK-2214 have been disclosed. The drug is referred to solely by its development code, MK-2214, in clinical trial registries and available information.