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RECRUITING Phase 2 ClinicalTrials.gov

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07033494

Registry updated: 2026-10-20
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Description

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

Interventions

  • MK-2214 (Biological)
    IV infusion
  • Placebo (Drug)
    IV infusion

Eligibility criteria

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

Conditions

Early Alzheimer's Disease

Locations

  • 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
  • CenExel- AMRI ( Site 1018) — Marlton, New Jersey, 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
  • 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
  • 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
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400) — Caba, Argentina
  • Southern Neurology ( Site 0306) — Kogarah, New South Wales, Australia
  • KARA Institute for Neurological Diseases ( Site 0302) — Macquarie Park, New South Wales, Australia
  • Austin Health ( Site 0300) — Ivanhoe, Victoria, Australia
  • HammondCare ( Site 0301) — Malvern, Victoria, Australia
  • Cliniques universitaires Saint-Luc ( Site 3001) — Brussels, Bruxelles-Capitale, Region de, Belgium
  • UZ Leuven ( Site 3000) — Leuven, Vlaams-Brabant, Belgium
  • AZ Groeninge Campus Kennedylaan ( Site 3002) — Kortrijk, West-Vlaanderen, Belgium
  • Ottawa Memory Clinic ( Site 2001) — Ottawa, Ontario, Canada
  • Sunnybrook Research Institute ( Site 2003) — Toronto, Ontario, Canada
  • Toronto Western Hospital ( Site 2004) — Toronto, Ontario, Canada
  • Clinique Mémoire de Montreal ( Site 2000) — Montreal, Quebec, Canada
  • National Center for Geriatrics and Gerontology ( Site 9002) — Ōbu, Aichi-ken, Japan
  • Chibaken Saiseikai Narashino Hospital ( Site 9000) — Narashino, Chiba, Japan
  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016) — Kawasaki, Kanagawa, Japan
  • Mie University Hospital ( Site 9011) — Tsu, Mie-ken, Japan
  • Katayama Medical Clinic ( Site 9005) — Kurashiki, Okayama-ken, Japan
  • Hatsuta Neurology Clinic ( Site 9017) — Hirakata, Osaka, Japan
  • National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004) — Kanzaki-gun, Saga-ken, Japan
  • Tokyo Medical University Hospital ( Site 9003) — Shinjuku, Tokyo, Japan
  • 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
  • Brain Research Center Den Bosch B.V. ( Site 5001) — 's-Hertogenbosch, North Brabant, Netherlands
  • Brain Research Center. ( Site 5000) — Amsterdam, North Holland, Netherlands
  • Brain Research Center Zwolle ( Site 5002) — Zwolle, Overijssel, Netherlands
  • National Neuroscience Institute ( Site 0101) — Singapore, Central Singapore, Singapore
  • Tan Tock Seng Hospital ( Site 0102) — Singapore, Central Singapore, Singapore
  • 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
  • Hospital Universitari Mutua Terrassa ( Site 6004) — Terrassa, Barcelona, Spain
  • Fundació ACE ( Site 6003) — Barcelona, Catalonia, Spain
  • Hospital del Mar ( Site 6001) — Barcelona, Spain
  • Hospital Clinic i Provincial ( Site 6002) — Barcelona, Spain
  • Scottish Brain Sciences Aberdeen ( Site 8001) — Aberdeen, Aberdeen City, United Kingdom
  • Scottish Brain Sciences ( Site 8000) — Edinburgh, Edinburgh, City of, United Kingdom
  • Moorgreen Hospital ( Site 8004) — Southampton, Hampshire, United Kingdom
  • Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006) — London, London, City of, United Kingdom
  • Warneford Hospital ( Site 8007) — Oxford, Oxfordshire, United Kingdom
  • Remind UK ( Site 8003) — Bath, Somerset, United Kingdom
  • Re:Cognition Health - Birmingham ( Site 8002) — Birmingham, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record