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Alzheimer Disease / MK-2214 · Phase 1 Trial
ClinicalTrials.gov · September 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 1 trial registration for MK-2214, a candidate Alzheimer's disease therapy, designed to assess safety, tolerability, and pharmacokinetics in adults with mild cognitive impairment or mild-to-moderate Alzheimer's disease. No results are posted in this registry record, so efficacy, safety, or biomarker findings cannot be evaluated. The study focused on dose escalation, CSF penetration, and target engagement (phospho-tau in CSF) as primary outcomes.
Phase 1, Interventional, Randomized, Sequential, Double masking, Treatment purpose. Alzheimer Disease; age from 50 Years; to 80 Years; accepts healthy volunteers. Intervention: Panel A: MK-2214 20 mg; Panel B: MK-2214 100 mg; Panel C: MK-2214 500 mg; Panel D: MK-2214 2000 mg. Compared with: Placebo — Placebo Comparator. n = 34. 12 sites: United States.
This is a completed Phase 1 trial registration for MK-2214, a candidate Alzheimer's disease therapy, designed to assess safety, tolerability, and pharmacokinetics in adults with mild cognitive impairment or mild-to-moderate Alzheimer's disease. No results are posted in this registry record, so efficacy, safety, or biomarker findings cannot be evaluated. The study focused on dose escalation, CSF penetration, and target engagement (phospho-tau in CSF) as primary outcomes.
This is a registry record with no posted results; no efficacy, safety, or biomarker findings are available. No information on dose levels tested, adverse events observed, or success/failure against the primary hypothesis is provided in this registry entry.
No clinical impact can be determined from this registry record, as no results are reported. Professionals should await peer-reviewed publication of safety, pharmacokinetic, and biomarker outcomes before interpreting the trial's contribution to the field.
This is a Phase 1 safety and pharmacokinetic study with no reported results; registry records of active or completed trials without posted outcomes represent early-stage work and cannot support efficacy or clinical claims.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be determined from this registry record, as no results are reported. Professionals should await peer-reviewed publication of safety, pharmacokinetic, and biomarker outcomes before interpreting the trial's contribution to the field.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05466422). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 34 participants (ACTUAL). Conditions: Alzheimer Disease. Interventions: BIOLOGICAL: MK-2214; DRUG: Placebo. Primary outcome measures: Number of Participants Who Experienced an Adverse Event (AE) , Up to approximately 297 days; Number of Participants Who Discontinued Study Treatment Due to an AE , Up to approximately 57 days; Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of MK-2214 in Serum After First Dose (Day 1) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29; AUC0-28 of MK-2214 in Serum After Third Dose (Day 57) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297; Maximum Serum Concentration (Cmax) of MK-2214 After First Dose (Day 1) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29; Cmax of MK-2214 After Third Dose (Day 57) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297; Time of Maximum Serum Concentration (Tmax) of MK-2214 After First Dose (Day 1) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29; Tmax of MK-2214 After Third Dose (Day 57) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297; Apparent Half-Life (T1/2) of MK-2214 in Serum After Third Dose (Day 57) , Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297; Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 , Day 85; Free Phospho-Tau Concentration in CSF , Day 85. Brief summary: 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
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