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Recruiting Phase 2

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

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About this study

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

Condition
Early Alzheimer's Disease
Tested
MK-2214, Placebo
Sponsor
Merck Sharp & Dohme LLC

Who can join

Age
50 to 85 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 50 years
  • Maximum age: 85 years
  • Study condition: Early Alzheimer's Disease
  • 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 15

  • 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

80 sites, 80 recruiting

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)

Caba, Argentina

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

Austin Health ( Site 0300)

Ivanhoe, Victoria, Australia

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

and 74 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.