NCT05466422

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	MK-2214	MK-2214 in escalating doses as an IV infusion on Days 1, 29, and 57
DRUG	Placebo	Placebo as an IV infusion on Days 1, 29, and 57

Timeline

• Start date: 2022-09-20
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2022-07-20
• Last updated: 2025-08-27

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study