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Recruiting Phase 2 NCT07033494

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

Phase 2 – studying effectiveness and dosage
Conditions: Early Alzheimer's Disease

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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 participate
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
Locations 9
Argentina (1)
Organizacion Medica de Investigacion ( Site 0401)
Ciudad de Buenos Aires , Buenos Aires F.D.
Study Coordinator
Australia (1)
Southern Neurology ( Site 0306)
Kogarah , New South Wales
Study Coordinator
Belgium (1)
Cliniques universitaires Saint-Luc ( Site 3001)
Brussels , Bruxelles-Capitale, Region de
Study Coordinator
Japan (1)
National Center for Geriatrics and Gerontology ( Site 9002)
Ōbu , Aichi-ken
Study Coordinator
Netherlands (1)
Brain Research Center Den Bosch B.V. ( Site 5001)
's-Hertogenbosch , North Brabant
Study Coordinator
South Korea (1)
Hanyang University Hospital ( Site 0200)
Seoul
Study Coordinator
Spain (1)
Hospital Universitari Mutua Terrassa ( Site 6004)
Terrassa , Barcelona
Study Coordinator
United Kingdom (1)
Scottish Brain Sciences Aberdeen ( Site 8001)
Aberdeen , Aberdeen City
Study Coordinator
United States (1)
Irvine Clinical Research ( Site 1041)
Irvine , California
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
16.07.2025
Completion date
30.04.2029
Registry ID
NCT07033494
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.