MK-2214 for Alzheimer's Disease

Recruiting at 15 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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.

Inclusion Criteria

Participant is in overall good health based on medical history and laboratory safety tests

BMI between 18.5 and 35 kg/m^2

Have a Mini-Mental State Examination (MMSE) >12 at the prestudy visit

Exclusion Criteria

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

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

I am on ongoing medication for an active autoimmune disease.

Treatment Details

Interventions

• MK-2214 (Other)
• Placebo (Drug)

Trial Overview 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).

Participant Groups

Group I: MK-2214 Experimental Treatment 1 Intervention

Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo as an IV infusion on Days 1, 29, and 57.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University