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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
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). Optional healthy older participants (Part 2) may receive MK-2214 at dose levels determined by criteria met in Part 1.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: MK-2214 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MK-2214
Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57.
 Biological: MK-2214
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.
 Drug: Placebo
Placebo as an IV infusion on Days 1, 29, and 57


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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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      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05466422    
Other Study ID Numbers: 2214-002
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
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders