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

Official title

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

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

Interventions

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

Primary outcome measures

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

Secondary outcome measures (7)

• Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score [Time frame: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV [Time frame: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr [Time frame: Baseline, up to approximately 23 months]
• Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI [Time frame: Baseline, up to approximately 23 months]
• Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score [Time frame: 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 [Time frame: Baseline, up to approximately 23 months]
• Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score [Time frame: Baseline, up to approximately 23 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 36 centers

• 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
• … and 28 more centers

Japan · 10 centers

• 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
• … and 2 more centers

United Kingdom · 7 centers

• 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

Australia · 4 centers

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

Canada · 4 centers

• 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

Spain · 4 centers

• 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

Argentina · 3 centers

• 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

Belgium · 3 centers

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

Netherlands · 3 centers

• 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 centers

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

Singapore · 2 centers

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗