What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine), have known side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine can lead to dizziness, headache, confusion, and constipation. Newer treatments like aducanumab, which targets amyloid plaques, may cause amyloid-related imaging abnormalities (ARIA), including brain swelling and microhemorrhages. These side effects should be discussed with a healthcare provider to tailor the best treatment plan for the patient.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease that aim to modulate its pathophysiology. Cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine are commonly used to increase cholinergic transmission and provide symptomatic relief in patients with mild to moderate Alzheimer's Disease. Additionally, memantine, an NMDA receptor antagonist, is approved for moderate to severe Alzheimer's Disease and can be used alone or in combination with cholinesterase inhibitors. These treatments offer modest benefits in cognition and global functioning but do not alter the underlying disease trajectory.

What other types of research exist?

Promising novel alternatives to MK-2214 for Alzheimer's Disease patients in 2024 include: 1) Lecanemab, an anti-amyloid beta protofibril antibody recently approved by the FDA, which has shown to slow cognitive decline in early AD. 2) Donanemab, another anti-amyloid antibody, which has demonstrated significant slowing of cognitive and functional decline in clinical trials. 3) ALZ-801, an oral agent targeting amyloid beta oligomers, currently in Phase 3 trials, showing potential in reducing cognitive decline. 4) Tau protein inhibitors like semorinemab, which have shown promise in reducing tau pathology and slowing disease progression in clinical trials.

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MK-2214 for Alzheimer's Disease

Phase 1

Recruiting

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

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.

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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.