The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment (MCI) or mild-to-moderate Alzheimer's Disease (AD). The primary hypothesis (Part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is \>0.3 nanomolar (nM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)
Glendale, California, United States
Collaborative Neuroscience Research, LLC ( Site 0009)
Los Alamitos, California, United States
Number of Participants Who Experience At Least One Adverse Event (AE)
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.
Time frame: Up to approximately 297 days
Number of Participants Who Discontinue Study Treatment Due to an AE
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.
Time frame: Up to approximately 57 days
Serum Area Under the Concentration-Time Curve of MK-2214 from Time 0 to 28 Hours (AUC0-28) After First and Third Dose
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.
Time frame: At designated time points (up to 85 days)
Serum Maximum Concentration (Cmax) of MK-2214 After First and Third Dose
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.
Time frame: At designated time points (up to 85 days)
Serum Time to Maximum Concentration (Tmax) of MK-2214 After First and Third Dose
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.
Time frame: At designated time points (up to 85 days)
Serum Apparent Terminal Half-Life (t1/2) of MK-2214 After First and Third Dose
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NRC Research Institute ( Site 0015)
Orange, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, United States
Research Centers of America ( Hollywood ) ( Site 0004)
Hollywood, Florida, United States
K2 Medical Research ( Site 0005)
Maitland, Florida, United States
Charter Research - Winter Park ( Site 0012)
Orlando, Florida, United States
Progressive Medical Research-Alzheimer's Team ( Site 0013)
Port Orange, Florida, United States
Charter Research - Lady Lake ( Site 0011)
The Villages, Florida, United States
CenExel iResearch, LLC ( Site 0002)
Decatur, Georgia, United States
...and 2 more locations
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.
Time frame: At designated time points (up to 85 days)
Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 (C85d)
CSF concentration of MK-2214 will be presented for Day 85.
Time frame: Day 85
Percentage change from baseline to Day 29 in free phospho-tau in CSF
Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100\* free phospho-tau / baseline).
Time frame: Baseline and Day 29 pre-dose
Percentage change from baseline to Day 85 in free phospho-tau in CSF
Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100\* free phospho-tau / baseline).
Time frame: Baseline and Day 85