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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 297 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 297 days
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on ongoing medication for an active autoimmune disease.I do not have any unstable or poorly controlled health conditions.I have been treated with aducanumab or similar therapy in the past 6 months.I have had cancer before.I haven't had biological therapy or immunoglobulin in the time frame required.I haven't had non-live vaccines around my treatment, except for COVID-19 or flu shots.I am on high-dose steroids or other drugs that weaken my immune system.I have experienced a slow decline in my memory and daily functioning over the last year.I have not had major surgery or lost a significant amount of blood in the last 4 weeks.I do not have any major active neurological diseases, except for Alzheimer's or mild cognitive impairment.I cannot safely undergo a spinal tap due to bleeding disorders or certain medications.Your score on a memory and thinking test is between 12 and 28.Your body mass index (BMI) is between 18.5 and 35, which is a measure of your weight in relation to your height.
Research Study Groups:
This trial has the following groups:- Group 1: MK-2214
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05466422 — Phase 1