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

Официальное название

A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Обзор

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

Вмешательства

• Биопрепарат MK-2214
  IV infusion
• Препарат Placebo
  IV infusion

Первичные конечные точки

• Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) [Срок оценки: Baseline, up to approximately 23 months]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 26 months]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 23 months]

Вторичные конечные точки (7)

• Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score [Срок оценки: Baseline, up to approximately 23 months]
• Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score [Срок оценки: Baseline, up to approximately 23 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 36 центров

• Irvine Clinical Research ( Site 1041) — Irvine
• Healthy Brain Clinic ( Site 1005) — Long Beach
• Inglewood Clinical ( Site 1062) — Los Angeles
• Anderson Clinical Research ( Site 1024) — Redlands
• UCSF Memory and Aging Center ( Site 1031) — San Francisco
• Syrentis Clinical Research ( Site 1001) — Santa Ana
• Yale University, Alzheimer's Disease Research Unit ( Site 1059) — New Haven
• JEM Research Institute ( Site 1046) — Atlantis
• … и ещё 28 центров

Япония · 10 центров

• National Center for Geriatrics and Gerontology ( Site 9002) — Ōbu
• Chibaken Saiseikai Narashino Hospital ( Site 9000) — Narashino
• Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016) — Kawasaki
• Mie University Hospital ( Site 9011) — Tsu
• Katayama Medical Clinic ( Site 9005) — Kurashiki
• National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004) — Kanzaki-gun
• Tokyo Medical University Hospital ( Site 9003) — Shinjuku
• Inage Neurology and Memory Clinic ( Site 9001) — Chiba
• … и ещё 2 центра

Великобритания · 7 центров

• Scottish Brain Sciences Aberdeen ( Site 8001) — Aberdeen
• Scottish Brain Sciences ( Site 8000) — Edinburgh
• Moorgreen Hospital ( Site 8004) — Southampton
• Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006) — London
• Warneford Hospital ( Site 8007) — Oxford
• Remind UK ( Site 8003) — Bath
• Re:Cognition Health - Birmingham ( Site 8002) — Birmingham

Австралия · 4 центра

• Southern Neurology ( Site 0306) — Kogarah
• KARA Institute for Neurological Diseases ( Site 0302) — Macquarie Park
• Austin Health ( Site 0300) — Ivanhoe
• HammondCare ( Site 0301) — Malvern

Канада · 4 центра

• Ottawa Memory Clinic ( Site 2001) — Ottawa
• Sunnybrook Research Institute ( Site 2003) — Toronto
• Toronto Western Hospital ( Site 2004) — Toronto
• Clinique Mémoire de Montreal ( Site 2000) — Montreal

Испания · 4 центра

• Hospital Universitari Mutua Terrassa ( Site 6004) — Terrassa
• Fundació ACE ( Site 6003) — Barcelona
• Hospital del Mar ( Site 6001) — Barcelona
• Hospital Clinic i Provincial ( Site 6002) — Barcelona

Аргентина · 3 центра

• Organizacion Medica de Investigacion ( Site 0401) — Ciudad de Buenos Aires
• Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site — Ciudad de Buenos Aires
• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site — Caba

Бельгия · 3 центра

• Cliniques universitaires Saint-Luc ( Site 3001) — Brussels
• UZ Leuven ( Site 3000) — Leuven
• AZ Groeninge Campus Kennedylaan ( Site 3002) — Kortrijk

Нидерланды · 3 центра

• Brain Research Center Den Bosch B.V. ( Site 5001) — 's-Hertogenbosch
• Brain Research Center. ( Site 5000) — Amsterdam
• Brain Research Center Zwolle ( Site 5002) — Zwolle

South Korea · 3 центра

• Hanyang University Hospital ( Site 0200) — Seoul
• Samsung Medical Center ( Site 0202) — Seoul
• Ewha Womans University Seoul Hospital ( Site 0201) — Seoul

Сингапур · 2 центра

• National Neuroscience Institute ( Site 0101) — Singapore
• Tan Tock Seng Hospital ( Site 0102) — Singapore

Идентификаторы

NCT: NCT07033494 · 2214-004 · MK-2214-004 · 2024-519190-19-00 · U1111-1314-8296 · jRCT2031250299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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