Alzheimer DiseasePhase 1NCT05466422

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)

A Phase 1 study testing MK-2214 in people with Alzheimer Disease, run by Merck Sharp & Dohme LLC at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease
What is being tested?: MK-2214
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 12 sitesUnited States
Study dates: 20 Sep 2022to 3 Jul 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

CenExel iResearch, LLC ( Site 0002)
Decatur, Georgia, 30030
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)
Glendale, California, 91206
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, 33009
Research Centers of America ( Hollywood ) ( Site 0004)
Hollywood, Florida, 33024
Collaborative Neuroscience Research, LLC ( Site 0009)
Los Alamitos, California, 90720
K2 Medical Research ( Site 0005)
Maitland, Florida, 32751
Neuro-Behavioral Clinical Research ( Site 0016)
North Canton, Ohio, 44720
NRC Research Institute ( Site 0015)
Orange, California, 92868
Charter Research - Winter Park ( Site 0012)
Orlando, Florida, 32803
Progressive Medical Research-Alzheimer's Team ( Site 0013)
Port Orange, Florida, 32127
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)
Princeton, New Jersey, 08540
Charter Research - Lady Lake ( Site 0011)
The Villages, Florida, 32162

Other trials in United States

About this study

Official title: A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-2214 in adults with mild cognitive impairment or mild-to-moderate Alzheimer's Disease. The primary hypothesis (Part 1) is that at a generally well-tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is >0.3 nanomolar

Read the detailed description

As specified by Phase 1 flexible language in the protocol, modifications to the dose or dosing regimen could be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses could be adjusted based on evaluation of safety, tolerability, and pharmacokinetic data observed in previous panels.

Part 2 was optional and was not conducted.

Conditions: Alzheimer Disease
Being tested: MK-2214, Placebo
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-2214Biological
IV infusion
PlaceboDrug
IV infusion

Study groups in NCT05466422
Study group	Role	What they receive
Panel A: MK-2214 20 mg	Experimental	Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57). Receives: Biological: MK-2214
Panel B: MK-2214 100 mg	Experimental	Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). Receives: Biological: MK-2214
Panel C: MK-2214 500 mg	Experimental	Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). Receives: Biological: MK-2214
Panel D: MK-2214 2000 mg	Experimental	Participants were randomized to receive MK-2214 2000 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57). Receives: Biological: MK-2214
Placebo	Placebo comparator	Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was reported.
Measured: Up to approximately 297 days
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was reported.
Measured: Up to approximately 57 days
Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of MK-2214 in Serum After First Dose (Day 1)
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after first dose (Day 1).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29
AUC0-28 of MK-2214 in Serum After Third Dose (Day 57)
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after third dose (Day 57).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297
Maximum Serum Concentration (Cmax) of MK-2214 After First Dose (Day 1)
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after first dose (Day 1).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29
Cmax of MK-2214 After Third Dose (Day 57)
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after third dose (Day 57).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297
Time of Maximum Serum Concentration (Tmax) of MK-2214 After First Dose (Day 1)
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after first dose (Day 1).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29
Tmax of MK-2214 After Third Dose (Day 57)
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after third dose (Day 57).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297
Apparent Half-Life (T1/2) of MK-2214 in Serum After Third Dose (Day 57)
T1/2 was defined as the apparent half-life of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine t1/2 of MK-2214 in serum after third dose (Day 57).
Measured: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297
Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85
Concentration of MK-2214 in CSF was defined as the CSF exposure of MK-2214. A CSF sample was to be collected on Day 85.
Measured: Day 85
Free Phospho-Tau Concentration in CSF
Concentration of free phospo-tau in CSF was defined as free phospho-tau levels in CSF after study treatment administration (MK-2214 or placebo). A CSF sample was to be collected on Day 85.
Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20223 Jul 2025

First posted20 Jul 2022
Study start20 Sep 2022
Primary completion3 Jul 2025
Study completion3 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05466422
Sponsor's protocol ID: 2214-002
Other IDs: MK-2214-002
Status last verified: Aug 2026
First submitted: 18 Jul 2022
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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