A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05466422|
Recruitment Status : Recruiting
First Posted : July 20, 2022
Last Update Posted : May 25, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Biological: MK-2214 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease|
|Actual Study Start Date :||September 20, 2022|
|Estimated Primary Completion Date :||November 15, 2024|
|Estimated Study Completion Date :||November 15, 2024|
Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57.
MK-2214 in escalating doses as an IV infusion on Days 1, 29, and 57
Placebo Comparator: Placebo
Participants will receive placebo as an IV infusion on Days 1, 29, and 57.
Placebo as an IV infusion on Days 1, 29, and 57
- Number of Participants Who Experience At Least One Adverse Event (AE) [ Time Frame: Up to approximately 297 days ]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.
- Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 57 days ]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.
- Serum Area Under the Concentration-Time Curve of MK-2214 from Time 0 to 28 Hours (AUC0-28) After First and Third Dose [ Time Frame: At designated time points (up to 85 days) ]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.
- Serum Maximum Concentration (Cmax) of MK-2214 After First and Third Dose [ Time Frame: At designated time points (up to 85 days) ]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.
- Serum Time to Maximum Concentration (Tmax) of MK-2214 After First and Third Dose [ Time Frame: At designated time points (up to 85 days) ]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.
- Serum Apparent Terminal Half-Life (t1/2) of MK-2214 After First and Third Dose [ Time Frame: At designated time points (up to 85 days) ]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.
- Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 (C85d) [ Time Frame: Day 85 ]CSF concentration of MK-2214 will be presented for Day 85.
- Percentage change from baseline to Day 29 in free phospho-tau in CSF [ Time Frame: Baseline and Day 29 pre-dose ]Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100* free phospho-tau / baseline).
- Percentage change from baseline to Day 85 in free phospho-tau in CSF [ Time Frame: Baseline and Day 85 ]Free phospho-tau in CSF will be determined for participants using the individual percent of baseline values (100* free phospho-tau / baseline).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
The key Inclusion Criteria include but are not limited to the following:
- Participant is in overall good health based on medical history and laboratory safety tests
- BMI between 18.5 and 35 kg/m2
Part 1 Only:
- History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening
- Have an Mini-Mental State Examination (MMSE) >12 and <28 at the prestudy visit
- Modified Hachinski Ischemic Score (MHIS) score <4 at the prestudy visit
The key Exclusion Criteria include but are not limited to the following:
- Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), has reported suicidal ideation with intent, with or without a plan or method
- History of unstable or poorly controlled endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
- History of clinically significant active neurological disease (except for AD or MCI for participants in Part 1)
- History of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy
- History of cancer (malignancy)
- History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
- Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy visit
- Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture
- Currently receiving or has received aducanumab or another anti-amyloid therapy within the last 6 months
- Has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year
- Has received any non-live vaccine starting from 14 days prior to first study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. Exception: COVID-19 and influenza vaccines may be administered
- Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05466422
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|United States, California|
|California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)||Recruiting|
|Glendale, California, United States, 91206|
|Contact: Study Coordinator 800-239-4367|
|Collaborative Neuroscience Research, LLC ( Site 0009)||Recruiting|
|Los Alamitos, California, United States, 90720|
|Contact: Study Coordinator 844-424-9494|
|United States, Florida|
|Velocity Clinical Research, Hallandale Beach ( Site 0001)||Recruiting|
|Hallandale Beach, Florida, United States, 33009|
|Contact: Study Coordinator 954-455-5757|
|Research Centers of America ( Hollywood ) ( Site 0004)||Recruiting|
|Hollywood, Florida, United States, 33024|
|Contact: Study Coordinator 954-990-7649|
|K2 Medical Research ( Site 0005)||Recruiting|
|Maitland, Florida, United States, 32751|
|Contact: Study Coordinator 407-500-5252|
|Charter Research - Lady Lake ( Site 0011)||Recruiting|
|The Villages, Florida, United States, 32162|
|Contact: Study Coordinator 352-441-2000|
|Charter Research - Winter Park ( Site 0012)||Recruiting|
|Winter Park, Florida, United States, 32792|
|Contact: Study Coordinator 407-337-3000|
|United States, Georgia|
|iResearch Atlanta ( Site 0002)||Recruiting|
|Decatur, Georgia, United States, 30030|
|Contact: Study Coordinator 404-537-1281|
|United States, New Jersey|
|Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)||Recruiting|
|Princeton, New Jersey, United States, 08540|
|Contact: Study Coordinator 609-921-3555|
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
MK-2214-002 ( Other Identifier: Merck )
|First Posted:||July 20, 2022 Key Record Dates|
|Last Update Posted:||May 25, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases