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Can an experimental infusion reach the brain to fight Alzheimer's?

NCT ID NCT05466422

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called MK-2214, given by IV infusion, in adults with mild cognitive impairment or mild-to-moderate Alzheimer's disease. The trial aims to see whether the drug is safe and tolerable, and whether it reaches meaningful levels in the brain and spinal fluid. It also checks how the drug affects a protein linked to Alzheimer's, called phospho-tau. This is an early-stage study with about 34 participants, and it will compare MK-2214 against a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-2214, an experimental biologic given by IV infusion
What this could lead to
If MK-2214 safely reaches meaningful levels in the brain and shows hints of lowering a key Alzheimer's protein, it could point toward a new way to slow the disease.
What could go wrong
This is a small, early-stage safety trial, so it cannot prove whether the drug works. The main goal is to check safety and how the drug moves through the body, and many early candidates do not advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Participant is in overall good health based on medical history and laboratory safety tests * Body mass index between 18.5 and 35 kg/m\^2 Part 1 (Mild Cognitive Impairment \[MCI\] and Mild-to-Moderate Alzheimer's Disease \[AD\]) Only: * History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening * Mini-Mental State Examination (MMSE) score \>12 at the prestudy visit * Modified Hachinski Ischemic Score (MHIS) \<4 at the prestudy visit Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 unstable or poorly controlled endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases * History of clinically significant active neurological disease (except for AD or MCI for participants in Part 1) * History of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy * History of cancer (malignancy) * 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 * Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) * Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy visit * Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture * Currently receiving or has received aducanumab or another anti-amyloid therapy within the last 6 months * Has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year * Has received any non-live vaccine starting from 14 days prior to first study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. Exception: coronavirus disease of 2019 (COVID-19) and influenza vaccines may be administered * Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)

    Glendale, California, 91206, United States

  • CenExel iResearch, LLC ( Site 0002)

    Decatur, Georgia, 30030, United States

  • Charter Research - Lady Lake ( Site 0011)

    The Villages, Florida, 32162, United States

  • Charter Research - Winter Park ( Site 0012)

    Orlando, Florida, 32803, United States

  • Collaborative Neuroscience Research, LLC ( Site 0009)

    Los Alamitos, California, 90720, United States

  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)

    Princeton, New Jersey, 08540, United States

  • K2 Medical Research ( Site 0005)

    Maitland, Florida, 32751, United States

  • NRC Research Institute ( Site 0015)

    Orange, California, 92868, United States

  • Neuro-Behavioral Clinical Research ( Site 0016)

    North Canton, Ohio, 44720, United States

  • Progressive Medical Research-Alzheimer's Team ( Site 0013)

    Port Orange, Florida, 32127, United States

  • Research Centers of America ( Hollywood ) ( Site 0004)

    Hollywood, Florida, 33024, United States

  • Velocity Clinical Research, Hallandale Beach ( Site 0001)

    Hallandale, Florida, 33009, United States

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