Early Alzheimer's Disease study: MK-2214
Official title A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
ClinicalTrials.gov ID: NCT07033494
What this study is testing
What is MK-2214?
MK-2214 is an investigational biological medicine being studied to see if it can slow changes in the brain for people with early Alzheimer's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether MK‑2214 can slow the spread of tau protein in the brain compared to a pretend treatment. It also looks at how safe and tolerable the drug is.
- Who it's for
- You may be able to join if you have early Alzheimer’s disease and meet the study’s health criteria.
- What's involved
- You will receive either MK‑2214 or a pretend treatment. You will have regular visits for brain scans and health checks. The study will monitor your safety and any side effects.
- Time commitment
- The study lasts about 12 months, with visits every few weeks for scans and health assessments.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
- Has a designated study partner who can fulfill the requirements of this study
- If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening
You likely can't join if
- Has a known history of stroke or cerebrovascular disease
- Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive...
- Has structural brain disease
- Has a history of seizures or epilepsy within 5 years before screening
- Has any other major central nervous system trauma, or infections that affect brain function
- Has major medical illness or unstable medical condition within 3 months before screening
See the full eligibility criteria
- Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
- Has a designated study partner who can fulfill the requirements of this study
- If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening
- Has a known history of stroke or cerebrovascular disease
- Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
- Has structural brain disease
- Has a history of seizures or epilepsy within 5 years before screening
- Has any other major central nervous system trauma, or infections that affect brain function
- Has major medical illness or unstable medical condition within 3 months before screening
- Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
- Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
- Has a bleeding disorder that is not under adequate control
- Has a history of malignancy occurring within 5 years of screening
- Has a risk factor for corrected QT interval (QTc) prolongation
- Has liver disease
- Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
- Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Redlands, California, United States
- San Francisco, California, United States
- Santa Ana, California, United States
- New Haven, Connecticut, United States
- Atlantis, Florida, United States
- Fort Myers, Florida, United States
- Maitland, Florida, United States
- Melbourne, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- New Port Richey, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- The Villages, Florida, United States
- Winter Park, Florida, United States
- Decatur, Georgia, United States
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Long Beach, California, United States; Los Angeles, California, United States; Redlands, California, United States; San Francisco, California, United States; Santa Ana, California, United States and 66 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.