Dementia Support Line
Study of MK2214 in people with early Alzheimer's disease
Status
Contact
The Clinical Trial Finder is for information only. To join a clinical trial you must meet the eligibility criteria set by the study and the research team will discuss this with you.
Trial description
What is the aim of the study?
This study is testing a new medicine called MK2214 in people with early Alzheimer's disease.
Researchers want to find out if MK2214 can help slow the build-up of a protein called tau in the brain. Tau can form harmful clumps that may damage brain cells and contribute to Alzheimer's disease.
The study will compare MK2214 with a placebo. A placebo looks the same as the study medicine but contains no active drug. Comparing the two helps researchers understand whether MK2214 works.
The main aims of the study are to see whether MK2214 can reduce tau levels in the brain and to check that it is safe.
What will participants be asked to do during the study?
Taking part in the study you will receive either MK-2214 or the placebo through a small tube placed into a vein in their arm. This is called an IV infusion or a drip. They will have this treatment once every 4 weeks while they are in the study.
You will be assigned to a treatment group by chance, like flipping a coin. Some people will receive MK2214 and some will receive the placebo.
Neither participants nor the study doctors will know who is receiving MK2214 or the placebo during the study. This helps ensure the results are fair and unbiased.
MK2214 is an experimental medicine. It has not yet been approved by health authorities for the treatment of Alzheimer's disease.
Find more information about why studies use blinding, randomisation and placebo controls.
During the study, you will:
Have blood and urine tests. These help doctors make sure the medicine is safe and check for any changes in health
- Have brain scans. These scans take detailed pictures of the brain so doctors can see how healthy it is and check that the treatment is safe
- Take part in activities and tests that look at memory, thinking skills, and wellbeing
If you would like more details about the tests, procedures, or number of visits, the study team can provide more information.
Eligibility criteria
Who can take part:
- People with mild cognitive impairment (MCI) or mild Dementia due to Alzhiemer’s disease
- People with a mini mental state examination (MMSE) score of 24-30 (inclusive) at screening
- To take part in this study you must have a study partner (a close friend or family member who spends at least 10 hours per week with you and can provide information at study visits)
- If you are taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), your dose must have been stable for at least 12 weeks prior to study screening.
- To take part in this study you must be able to speak, read, hear and understand the information given to them at the time of screening.
Who cannot take part:
- History of stroke or cerebrovascular disease
- History of seizures or epilepsy within 5 years of screening
- People who have had a major medical illness or an unstable medical condition within 3 months before screening
- People who are unwilling or unable to have computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scans
- A bleeding disorder
- Vitamin B12 or folate deficiency
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate
Clinical trial team
Age range
Recruitment start
Disease type
Mechanism of action
Trial locations
Length of participation
Eligibility criteria
Who can take part:
- People with mild cognitive impairment (MCI) or mild Dementia due to Alzhiemer’s disease
- People with a mini mental state examination (MMSE) score of 24-30 (inclusive) at screening
- To take part in this study you must have a study partner (a close friend or family member who spends at least 10 hours per week with you and can provide information at study visits)
- If you are taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), your dose must have been stable for at least 12 weeks prior to study screening.
- To take part in this study you must be able to speak, read, hear and understand the information given to them at the time of screening.
Who cannot take part:
- History of stroke or cerebrovascular disease
- History of seizures or epilepsy within 5 years of screening
- People who have had a major medical illness or an unstable medical condition within 3 months before screening
- People who are unwilling or unable to have computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scans
- A bleeding disorder
- Vitamin B12 or folate deficiency
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate