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

Summary

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (80)

• Irvine Clinical Research ( Site 1041), Irvine, California · RECRUITING
• Healthy Brain Clinic ( Site 1005), Long Beach, California · RECRUITING
• Inglewood Clinical ( Site 1062), Los Angeles, California · RECRUITING
• Anderson Clinical Research ( Site 1024), Redlands, California · RECRUITING
• UCSF Memory and Aging Center ( Site 1031), San Francisco, California · RECRUITING
• Syrentis Clinical Research ( Site 1001), Santa Ana, California · RECRUITING
• Yale University, Alzheimer's Disease Research Unit ( Site 1059), New Haven, Connecticut · RECRUITING
• JEM Research Institute ( Site 1046), Atlantis, Florida · RECRUITING
• Neuropsychiatric Research Center of Southwest Florida ( Site 1003), Fort Myers, Florida · RECRUITING
• K2 Medical Research ( Site 1047), Maitland, Florida · RECRUITING
• ClinCloud LLC ( Site 1039), Melbourne, Florida · RECRUITING
• Indago Research and Health Center Inc ( Site 1044), Miami Lakes, Florida · RECRUITING
• Aqualane Clinical Research ( Site 1035), Naples, Florida · RECRUITING
• Suncoast Clinical Research ( Site 1007), New Port Richey, Florida · RECRUITING
• Renstar Medical Research ( Site 1012), Ocala, Florida · RECRUITING
• Charter Research - Orlando ( Site 1051), Orlando, Florida · RECRUITING
• Axiom Brain Health ( Site 1029), Tampa, Florida · RECRUITING
• K2 Medical Research ( Site 1020), Tampa, Florida · RECRUITING
• Charter Research - Lady Lake ( Site 1019), The Villages, Florida · RECRUITING
• Conquest Research LLC ( Site 1053), Winter Park, Florida · RECRUITING
• CenExel iResearch, LLC ( Site 1015), Decatur, Georgia · RECRUITING
• Alexian Brothers Medical Center-Neurosciences ( Site 1017), Elk Grove Village, Illinois · RECRUITING
• Boston Center for Memory ( Site 1008), Newton, Massachusetts · RECRUITING
• Clinical Research Professionals ( Site 1004), Chesterfield, Missouri · RECRUITING
• The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064), Ridgewood, New Jersey · RECRUITING
• The Cognitive and Research Center of NJ ( Site 1057), Springfield, New Jersey · RECRUITING
• CenExel- AMRI ( Site 1018), Toms River, New Jersey · RECRUITING
• Alzheimer Disease Research Center (ADRC) ( Site 1000), Albany, New York · RECRUITING
• Mid Hudson Medical Research ( Site 1050), New Windsor, New York · RECRUITING
• Basil Clinical ( Site 1065), Queens, New York · RECRUITING
• AMC Research, LLC ( Site 1006), Matthews, North Carolina · RECRUITING
• Insight Clinical Trials ( Site 1011), Independence, Ohio · RECRUITING
• Neuro-Behavioral Clinical Research ( Site 1028), North Canton, Ohio · RECRUITING
• Flourish Research ( Site 1048), Plymouth Meeting, Pennsylvania · RECRUITING
• Gadolin Research ( Site 1032), Beaumont, Texas · RECRUITING
• Horizon Clinical Research Center - Houston ( Site 1026), Cypress, Texas · RECRUITING
• Organizacion Medica de Investigacion ( Site 0401), Ciudad de Buenos Aires, Buenos Aires F.D., Argentina · RECRUITING
• Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404), Ciudad de Buenos Aires, Buenos Aires F.D., Argentina · RECRUITING
• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400), Caba, Argentina · RECRUITING
• Southern Neurology ( Site 0306), Kogarah, New South Wales, Australia · RECRUITING
• KARA Institute for Neurological Diseases ( Site 0302), Macquarie Park, New South Wales, Australia · RECRUITING
• Austin Health ( Site 0300), Ivanhoe, Victoria, Australia · RECRUITING
• HammondCare ( Site 0301), Malvern, Victoria, Australia · RECRUITING
• Cliniques universitaires Saint-Luc ( Site 3001), Brussels, Bruxelles-Capitale, Region de, Belgium · RECRUITING
• UZ Leuven ( Site 3000), Leuven, Vlaams-Brabant, Belgium · RECRUITING
• AZ Groeninge Campus Kennedylaan ( Site 3002), Kortrijk, West-Vlaanderen, Belgium · RECRUITING
• Ottawa Memory Clinic ( Site 2001), Ottawa, Ontario, Canada · RECRUITING
• Sunnybrook Research Institute ( Site 2003), Toronto, Ontario, Canada · RECRUITING
• Toronto Western Hospital ( Site 2004), Toronto, Ontario, Canada · RECRUITING
• Clinique Mémoire de Montreal ( Site 2000), Montreal, Quebec, Canada · RECRUITING
• National Center for Geriatrics and Gerontology ( Site 9002), Ōbu, Aichi-ken, Japan · RECRUITING
• Chibaken Saiseikai Narashino Hospital ( Site 9000), Narashino, Chiba, Japan · RECRUITING
• Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016), Kawasaki, Kanagawa, Japan · RECRUITING
• Mie University Hospital ( Site 9011), Tsu, Mie-ken, Japan · RECRUITING
• Katayama Medical Clinic ( Site 9005), Kurashiki, Okayama-ken, Japan · RECRUITING
• Hatsuta Neurology Clinic ( Site 9017), Hirakata, Osaka, Japan · RECRUITING
• National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004), Kanzaki-gun, Saga-ken, Japan · RECRUITING
• Tokyo Medical University Hospital ( Site 9003), Shinjuku, Tokyo, Japan · RECRUITING
• Inage Neurology and Memory Clinic ( Site 9001), Chiba, Japan · RECRUITING
• Kyushu University Hospital ( Site 9010), Fukuoka, Japan · RECRUITING
• Okayama City General Medical Center Okayama City Hospital ( Site 9008), Okayama, Japan · RECRUITING
• Brain Research Center Den Bosch B.V. ( Site 5001), 's-Hertogenbosch, North Brabant, Netherlands · RECRUITING
• Brain Research Center. ( Site 5000), Amsterdam, North Holland, Netherlands · RECRUITING
• Brain Research Center Zwolle ( Site 5002), Zwolle, Overijssel, Netherlands · RECRUITING
• National Neuroscience Institute ( Site 0101), Singapore, Central Singapore, Singapore · RECRUITING
• Tan Tock Seng Hospital ( Site 0102), Singapore, Central Singapore, Singapore · RECRUITING
• Hanyang University Hospital ( Site 0200), Seoul, South Korea · RECRUITING
• Samsung Medical Center ( Site 0202), Seoul, South Korea · RECRUITING
• Ewha Womans University Seoul Hospital ( Site 0201), Seoul, South Korea · RECRUITING
• Hospital Universitari Mutua Terrassa ( Site 6004), Terrassa, Barcelona, Spain · RECRUITING
• Fundació ACE ( Site 6003), Barcelona, Catalonia, Spain · RECRUITING
• Hospital del Mar ( Site 6001), Barcelona, Spain · RECRUITING
• Hospital Clinic i Provincial ( Site 6002), Barcelona, Spain · RECRUITING
• Scottish Brain Sciences Aberdeen ( Site 8001), Aberdeen, Aberdeen City, United Kingdom · RECRUITING
• Scottish Brain Sciences ( Site 8000), Edinburgh, Edinburgh, City of, United Kingdom · RECRUITING
• Moorgreen Hospital ( Site 8004), Southampton, Hampshire, United Kingdom · RECRUITING
• Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006), London, London, City of, United Kingdom · RECRUITING
• Warneford Hospital ( Site 8007), Oxford, Oxfordshire, United Kingdom · RECRUITING
• Remind UK ( Site 8003), Bath, Somerset, United Kingdom · RECRUITING
• Re:Cognition Health - Birmingham ( Site 8002), Birmingham, United Kingdom · RECRUITING