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 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 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. |
| 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...