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MK-2214 for Alzheimer's Disease

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 297 days

Summary

This trial is testing a new drug called MK-2214 to see if it is safe and how it behaves in the body. It targets adults with early memory and thinking problems, like mild cognitive impairment or mild-to-moderate Alzheimer's Disease. Researchers want to know if the drug reaches helpful levels in the brain fluid and stays there long enough to potentially help these conditions.

Who is the study for?
This trial is for adults with mild cognitive impairment or mild-to-moderate Alzheimer's Disease who are in good health, have a BMI between 18.5 and 35 kg/m2, and show a history of gradual cognitive decline over at least one year. Participants must score within certain ranges on mental state and ischemic assessments.
What is being tested?
The study tests the safety and effects of MK-2214 on patients with Alzheimer's-related cognitive issues. It measures how much drug reaches the brain fluid and its impact compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
While specific side effects aren't listed here, they typically monitor for any adverse reactions related to bodily systems like gastrointestinal, cardiovascular, or neurological functions during such trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 297 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 297 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 (C85d)
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience At Least One Adverse Event (AE)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-2214Experimental Treatment1 Intervention
Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo as an IV infusion on Days 1, 29, and 57.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease include cholinesterase inhibitors and memantine. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, work by increasing levels of acetylcholine in the brain, which is important for memory and learning. Memantine, an NMDA receptor antagonist, helps regulate glutamate activity to protect neurons from damage. These treatments are important for Alzheimer's patients as they aim to improve cognitive function and slow symptom progression. The trial MK-2214 is exploring a new approach that may offer additional therapeutic benefits by potentially modulating different aspects of Alzheimer's Disease pathophysiology.
A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,755 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,386 Total Patients Enrolled

Media Library

MK-2214 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05466422 — Phase 1
Alzheimer's Disease Research Study Groups: MK-2214, Placebo
Alzheimer's Disease Clinical Trial 2023: MK-2214 Highlights & Side Effects. Trial Name: NCT05466422 — Phase 1
MK-2214 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05466422 — Phase 1
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05466422 — Phase 1
~9 spots leftby Jul 2025