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NCT05466422CompletedPhase 1

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-2214 in adults with mild cognitive impairment or mild-to-moderate Alzheimer's Disease. 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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
34 (actual)
First submitted
18 Jul 2022
Start date
20 Sept 2022
Primary completion date
3 Jul 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05466422

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 34
  • From 20 Sept 2022 to the primary completion date, 3 Jul 2025
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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: coronavirus disease of 2019 (COVID-19) and influenza vaccines may be administered
  • Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses

Other illness

  • 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)

Other

  • The main 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

Who the study is looking for

  • The main inclusion criteria include but are not limited to the following:
  • Participant is in overall good health based on medical history and laboratory safety tests
  • Body mass index between 18.5 and 35 kg/m\^2
    • Part 1 (Mild Cognitive Impairment \[MCI\] and Mild-to-Moderate Alzheimer's Disease \[AD\]) Only:
  • History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening
  • Mini-Mental State Examination (MMSE) score \>12 at the prestudy visit
  • Modified Hachinski Ischemic Score (MHIS) \<4 at the prestudy visit

Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CenExel iResearch, LLC ( Site 0002)
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)
Coordinator of this site? Confirm its status
GlendaleUnited StatesUnknown status
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Coordinator of this site? Confirm its status
HallandaleUnited StatesUnknown status
Research Centers of America ( Hollywood ) ( Site 0004)
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
Collaborative Neuroscience Research, LLC ( Site 0009)
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesUnknown status
K2 Medical Research ( Site 0005)
Coordinator of this site? Confirm its status
MaitlandUnited StatesUnknown status
Neuro-Behavioral Clinical Research ( Site 0016)
Coordinator of this site? Confirm its status
North CantonUnited StatesUnknown status
NRC Research Institute ( Site 0015)
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Charter Research - Winter Park ( Site 0012)
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Progressive Medical Research-Alzheimer's Team ( Site 0013)
Coordinator of this site? Confirm its status
Port OrangeUnited StatesUnknown status
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)
Coordinator of this site? Confirm its status
PrincetonUnited StatesUnknown status
Charter Research - Lady Lake ( Site 0011)
Coordinator of this site? Confirm its status
The VillagesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.