A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Официальное название

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

Обзор

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Вмешательства

• Препарат Trontinemab
  Participants will receive IV trontinemab
• Другое Placebo
  Participants will receive IV placebo

Первичные конечные точки

• Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [Срок оценки: Baseline - Week 72]

Вторичные конечные точки (12)

• Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) [Срок оценки: Baseline - Week 72]
• Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score [Срок оценки: Baseline - Week 72]
• Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) [Срок оценки: Baseline - Week 72]
• Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) [Срок оценки: Baseline - Week 72]
• Change from baseline in CDR-SB [Срок оценки: Baseline up to but excluding Week 72]
• Time to increase in Clinical Dementia Rating, Global Score (CDR-GS) [Срок оценки: Baseline - Week 72]
• Percentage of participants with adverse events (AEs) [Срок оценки: Baseline - Week 72]
• Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings [Срок оценки: Baseline - Week 72]
• Percentage of participants with infusion-related reactions (IRR) [Срок оценки: Baseline - Week 72]
• Percentage of participants with anti-drug antibodies (ADAs) to trontinemab [Срок оценки: Baseline - Week 72]
• Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan [Срок оценки: Baseline - Week 72]
• Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants [Срок оценки: Baseline - Week 72]

Критерии участия

Критерии включения

• Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
• Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
• Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
• Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
• Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
• Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
• A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
• Availability of a "study partner" as defined by the protocol

Критерии исключения

• Any evidence of a condition other than AD that may affect cognition
• History or presence of clinically significant cerebrovascular disease
• History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
• History or presence of clinically significant intracranial mass
• MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
• Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
• History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

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 · 33 центра

• Banner Alzheimer?s Institute — Phoenix
• Sun Valley Research Center, Inc. — Imperial
• Healthy Brain Clinic — Long Beach
• Oakland Clinical — Oakland
• Riverside Clinical — Riverside
• Cenexel California Neuroscience Research, LLC — Sherman Oaks
• Yale University — New Haven
• JEM Research LLC — Atlantis
• … и ещё 25 центров

Германия · 15 центров

• Universitaetsklinikum Erlangen — Erlangen
• Ambulates Gesundheitszentrum der Charité GmbH — Berlin
• ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic — Berlin
• German Center for Neurodegenerative Diseases (DZNE) — Bonn
• Universitätsklinikum Köln — Cologne
• Medizinische Fakultät Carl Gustav Carus — Dresden
• Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie — Homburg/Saar
• Universitätsklinikum Jena, Klinik für Neurologie — Jena
• … и ещё 7 центров

South Korea · 12 центров

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Польша · 11 центров

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Великобритания · 11 центров

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Япония · 10 центров

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Австралия · 9 центров

• Royal Prince Alfred Hospital — Camperdown
• Southern Neurology — Kogarah
• KaRa Institute of Neurological Diseases — Macquarie Park
• Flinders Medical Centre — Bedford Park
• Queen Elizabeth Hospital — Woodville
• Box Hill Hospital — Box Hill
• Austin Health — Heidelberg
• Alfred Hospital — Melbourne
• … и ещё 1 центр

Франция · 9 центров

• CHU Amiens Hopital Sud — Amiens Cedex1
• Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin — Bordeaux
• Groupement Hospitalier Est - Hôpital Neurologique — Bron
• CHU Dupruytren - Limoges — Limoges
• Hopital Gui de Chauliac — Montpellier
• Ch Pitie Salpetriere — Paris
• CHU de Rouen Hopital — Rouen
• Hop Guillaume Et Rene Laennec — Saint-Herblain
• … и ещё 1 центр

Канада · 8 центров

• Okanagan Clinical Trials — Kelowna
• Centricity Research — Halifax
• Parkwood Institute Main Building — London
• The Ottawa Memory Clinic — Ottawa
• Kawartha Centre - Redefining Healthy Aging — Peterborough
• Sunnybrook Health Sciences Centre — Toronto
• St. Michael's Hospital — Toronto
• Genge Partners Inc. — Montreal

Испания · 8 центров

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Бразилия · 6 центров

• L2 Ip Instituto de Pesquisas Clinicas Ltda ME — Brasília
• Instituto de Neurologia de Curitiba — Curitiba
• Clinica Clinilive ltda — Maringá
• Instituto do Cerebro do Rio Grande do Sul — Porto Alegre
• Clinica Neurologica — Joinville
• CEMEC - Centro Multidisciplinar de Estudos Clínicos — São Bernardo do Campo

Италия · 5 центров

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Швейцария · 4 центра

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Аргентина · 3 центра

• INECO Neurociencias Orono — Rosario
• CIER — C. A. B. A.
• Fundacion Scherbovsky — Mendoza

Дания · 3 центра

• Aalborg Universitetshospital — Aalborg
• Aarhus Universitetshospital Skejby — Aarhus N
• Rigshospitalet, Hukommelsesklinikken — København Ø

Нидерланды · 3 центра

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Идентификаторы

NCT: NCT07170150 · WN45447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗