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
- Diseases
- Alzheimer disease
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel iResearch, LLC ( Site 0002) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Velocity Clinical Research, Hallandale Beach ( Site 0001) Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Research Centers of America ( Hollywood ) ( Site 0004) Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Collaborative Neuroscience Research, LLC ( Site 0009) Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| K2 Medical Research ( Site 0005) Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Neuro-Behavioral Clinical Research ( Site 0016) Coordinator of this site? Confirm its status | North Canton | United States | Unknown status |
| NRC Research Institute ( Site 0015) Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Charter Research - Winter Park ( Site 0012) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Progressive Medical Research-Alzheimer's Team ( Site 0013) Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003) Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
| Charter Research - Lady Lake ( Site 0011) Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.