A clinical study of MK-2214 in people with early Alzheimer's disease
Information about the drug that will be tested in the study
Administration
Intravenous infusion every 4 weeks
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- An intravenous infusion of MK-2214
- An intravenous infusion of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The study will evaluate the safety and efficacy of MK-2214 in people with early Alzheimer's disease. Researchers want to know if giving MK-2214 can slow the spread of tau (protein that accumulates in Alzheimer’s disease and damage brain cells) In the brain.
How long will the treatment last?
- Around 2 years
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their memory, cognition, functional, behaviour and activities of daily living (CDR-SB, ADAS-Cog13, ADCS-ADL-MCI, iADRS)
- Undergo brain scans (PET imaging) to assess tau pathology
- Complete some laboratory tests and neurological examination to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 50 and 85 years old
- Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease
- Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
- If the person is taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), the dosing regimen must have been stable for at least 3 months prior to screening.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Diagnosis of a clinically relevant central nervous system disease other than Alzheimer’s disease dementia or major brain trauma that negatively impacts cognition or cognitive status chronically
- A disease that may interfere with the safety or study assessments (e.g., Human immunodeficiency virus, syphilis, hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases)
- Major medical illness or unstable medical condition
- History of malignancy, stroke, cerebrovascular disease, seizures or epilepsy
- Is unwilling or unable to undergo brain scans
- Residence in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT07033494
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT07033494
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in September 2025.
This document has been reviewed by a member of the European Dementia Carers Working Group.
