A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
Recruiting · NCT07033494 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
MK-2214Placebo
What this trial is about
Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it
Who can take part
Age range
50 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The main inclusion criteria include but are not limited to the following:
- 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
Exclusion criteria
- The main exclusion criteria include but are not limited to the following:
- 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
Where it is running
60 locations listed across 13 US states.
- Irvine Clinical Research ( Site 1041) - Irvine, California, United States
- Healthy Brain Clinic ( Site 1005) - Long Beach, California, United States
- Inglewood Clinical ( Site 1062) - Los Angeles, California, United States
- Anderson Clinical Research ( Site 1024) - Redlands, California, United States
- UCSF Memory and Aging Center ( Site 1031) - San Francisco, California, United States
- Syrentis Clinical Research ( Site 1001) - Santa Ana, California, United States
- Yale University, Alzheimer's Disease Research Unit ( Site 1059) - New Haven, Connecticut, United States
- JEM Research Institute ( Site 1046) - Atlantis, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida ( Site 1003) - Fort Myers, Florida, United States
- K2 Medical Research ( Site 1047) - Maitland, Florida, United States
- ClinCloud LLC ( Site 1039) - Melbourne, Florida, United States
- Indago Research and Health Center Inc ( Site 1044) - Miami Lakes, Florida, United States
- Aqualane Clinical Research ( Site 1035) - Naples, Florida, United States
- Suncoast Clinical Research ( Site 1007) - New Port Richey, Florida, United States
- Renstar Medical Research ( Site 1012) - Ocala, Florida, United States
- Charter Research - Orlando ( Site 1051) - Orlando, Florida, United States
- Axiom Brain Health ( Site 1029) - Tampa, Florida, United States
- K2 Medical Research ( Site 1020) - Tampa, Florida, United States
- Charter Research - Lady Lake ( Site 1019) - The Villages, Florida, United States
- Conquest Research LLC ( Site 1053) - Winter Park, Florida, United States
- CenExel iResearch, LLC ( Site 1015) - Decatur, Georgia, United States
- Alexian Brothers Medical Center-Neurosciences ( Site 1017) - Elk Grove Village, Illinois, United States
- Boston Center for Memory ( Site 1008) - Newton, Massachusetts, United States
- Clinical Research Professionals ( Site 1004) - Chesterfield, Missouri, United States
- The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064) - Ridgewood, New Jersey, United States
- The Cognitive and Research Center of NJ ( Site 1057) - Springfield, New Jersey, United States
- CenExel- AMRI ( Site 1018) - Toms River, New Jersey, United States
- Alzheimer Disease Research Center (ADRC) ( Site 1000) - Albany, New York, United States
- Mid Hudson Medical Research ( Site 1050) - New Windsor, New York, United States
- Basil Clinical ( Site 1065) - Queens, New York, United States
- AMC Research, LLC ( Site 1006) - Matthews, North Carolina, United States
- Insight Clinical Trials ( Site 1011) - Independence, Ohio, United States
- Neuro-Behavioral Clinical Research ( Site 1028) - North Canton, Ohio, United States
- Flourish Research ( Site 1048) - Plymouth Meeting, Pennsylvania, United States
- Gadolin Research ( Site 1032) - Beaumont, Texas, United States
- Horizon Clinical Research Center - Houston ( Site 1026) - Cypress, Texas, United States
- Hospital del Mar ( Site 6001) - Barcelona, Spain
- Hospital Clinic i Provincial ( Site 6002) - Barcelona, Spain
- Re:Cognition Health - Birmingham ( Site 8002) - Birmingham, United Kingdom
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400) - Caba, Argentina
- Inage Neurology and Memory Clinic ( Site 9001) - Chiba, Japan
- Kyushu University Hospital ( Site 9010) - Fukuoka, Japan
- Okayama City General Medical Center Okayama City Hospital ( Site 9008) - Okayama, Japan
- Hanyang University Hospital ( Site 0200) - Seoul, South Korea
- Samsung Medical Center ( Site 0202) - Seoul, South Korea
- Ewha Womans University Seoul Hospital ( Site 0201) - Seoul, South Korea
- Scottish Brain Sciences Aberdeen ( Site 8001) - Aberdeen, Aberdeen City, United Kingdom
- National Center for Geriatrics and Gerontology ( Site 9002) - Ōbu, Aichi-ken, Japan
- Hospital Universitari Mutua Terrassa ( Site 6004) - Terrassa, Barcelona, Spain
- Cliniques universitaires Saint-Luc ( Site 3001) - Brussels, Bruxelles-Capitale, Region de, Belgium
- Organizacion Medica de Investigacion ( Site 0401) - Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404) - Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
- Fundació ACE ( Site 6003) - Barcelona, Catalonia, Spain
- National Neuroscience Institute ( Site 0101) - Singapore, Central Singapore, Singapore
- Tan Tock Seng Hospital ( Site 0102) - Singapore, Central Singapore, Singapore
- Chibaken Saiseikai Narashino Hospital ( Site 9000) - Narashino, Chiba, Japan
- Scottish Brain Sciences ( Site 8000) - Edinburgh, Edinburgh, City of, United Kingdom
- Moorgreen Hospital ( Site 8004) - Southampton, Hampshire, United Kingdom
- Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016) - Kawasaki, Kanagawa, Japan
- Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006) - London, London, City of, United Kingdom
Showing 60 of 80 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →