MK-2214 for Alzheimer's Disease

Recruiting at 51 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Stroke, Seizures, CNS disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 23 months

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental treatment called MK-2214 to determine if it can slow Alzheimer's disease (AD), which affects memory and daily activities. Researchers aim to find out if MK-2214 can reduce the spread of tau, a damaging brain protein, compared to a placebo (a look-alike treatment with no active ingredient). They are also assessing the safety and tolerability of MK-2214. Suitable participants include those with mild memory problems or mild dementia due to Alzheimer's, who have a study partner and have maintained a stable Alzheimer's medication plan for at least three months. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are on an approved Alzheimer's therapy, your medication dose must have been stable for at least 3 months before joining the trial.

Is there any evidence suggesting that MK-2214 is likely to be safe for humans?

Research shows that MK-2214 is under study to assess its safety and tolerability. People with mild cognitive impairment, an early stage of memory loss, have taken MK-2214 in previous studies. Researchers evaluated how well these patients tolerated the treatment.

Although detailed safety data is not provided here, MK-2214's progression to a Phase 2 trial indicates it was safe enough in earlier, smaller studies to be tested in a larger group.

Currently, researchers closely monitor MK-2214 for any side effects or issues. This careful observation helps ensure its safety for potential study participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's disease?

Unlike the standard Alzheimer's treatments, which typically focus on managing symptoms or slowing progression through cholinesterase inhibitors and memantine, MK-2214 offers a novel approach. Researchers are excited about MK-2214 because it is administered via intravenous infusion every four weeks and may target underlying disease mechanisms more effectively. This could potentially lead to improved cognitive outcomes and a shift in how Alzheimer's is treated, providing hope for a condition with limited options.

What evidence suggests that MK-2214 might be an effective treatment for Alzheimer's disease?

Research has shown that MK-2214 is designed to slow the spread of a protein called tau in the brain. Tau buildup harms brain cells in Alzheimer's disease. In this trial, participants will receive either MK-2214 or a placebo to compare their effects. Early results suggest that MK-2214 may slow these changes compared to a placebo. Researchers are studying the treatment to determine its potential benefits for memory and thinking problems. While detailed information on its effectiveness in people is still being gathered, this approach targets a crucial aspect of Alzheimer's progression. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people with early Alzheimer's Disease, who can perform daily tasks with minimal assistance. Participants must be able to have brain scans and take study medication as directed. Those with other neurological conditions or unstable medical issues may not qualify.

Inclusion Criteria

My Alzheimer's medication dose has been stable for the last 3 months.

Has a designated study partner who can fulfill the requirements of this study

I have mild memory problems or mild dementia because of Alzheimer's.

Exclusion Criteria

Has a risk factor for corrected QT interval (QTc) prolongation

Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

I have liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-2214 or placebo via IV infusion every 4 weeks

23 months

Visits every 4 weeks for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MK-2214

Trial Overview The trial tests MK-2214, a new treatment aimed at slowing Alzheimer's progression by targeting tau protein in the brain. It will be compared to a placebo—a substance without active medication—to measure effectiveness and safety.

How Is the Trial Designed?

Group I: MK-2214 Experimental Treatment 1 Intervention

Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a placebo via IV infusion q4w during the study.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07033494

NCT07033494 | A Clinical Study of MK-2214 in People ... MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: If MK-2214 slows the spread of tau in the brain compared to placebo.

2. memory.ucsf.edu memory.ucsf.edu/research-trials/mk-2214

A Clinical Study of MK-2214 in People with Early Alzheimer's ... Researchers aim to determine whether MK-2214 can slow the spread of tau protein in the brain, compared to a placebo.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05466422

NCT05466422 | A Study of MK-2214 in Adults With Mild ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive ...

4. withpower.com withpower.com/trial/phase-1-alzheimer-disease-8-2022-6cbcb

MK-2214 for Alzheimer's Disease · Info for Participants 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.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-of-mk-2214-to-slow-disease-progression-in-people-with-early-alzheimers-disease/

Study of MK-2214 to slow disease progression in people ... This study focuses on people with Early Alzheimer's Disease, a condition that affects memory and thinking abilities.

6. merckclinicaltrials.com merckclinicaltrials.com/trial/nct05466422/

A Study of MK-2214 in Adults With Mild Cognitive Impairment ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment ...

7. trialstransparency.msdclinicaltrials.com trialstransparency.msdclinicaltrials.com/Study.aspx?id=2214-002&kw=alzheimer's

Study - MSD Clinical Trials The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05466422

NCT05466422 | A Study of MK-2214 in Adults With Mild ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment ...