A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Официальное название

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Обзор

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Вмешательства

• Препарат Donanemab
  Donanemab administered IV
• Препарат Placebo
  Placebo administered IV

Первичные конечные точки

• Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Срок оценки: Baseline through Week 52]

Вторичные конечные точки (9)

• Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS) [Срок оценки: Baseline through Week 52]
• Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13) [Срок оценки: Baseline through Week 52]
• Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL) [Срок оценки: Baseline through Week 52]
• Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS) [Срок оценки: Baseline through Week 52]
• Change from Baseline in Brain Amyloid Plaque Levels [Срок оценки: Baseline through Week 52]
• Trough Concentration at Steady State [Срок оценки: Baseline through Week 52]
• Maximum Concentration at Steady State [Срок оценки: Baseline through Week 52]
• Antidrug Antibodies (ADA) Against Donanemab [Срок оценки: Baseline through Week 52]
• Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants [Срок оценки: Baseline through Week 52]

Критерии участия

Критерии включения

• Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
• Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
• Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
• Meet plasma P-tau217 criteria.
• Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
• Have a CSF result consistent with the presence of alpha-synuclein pathology.
• Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

Критерии исключения

• Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
• Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
• Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
• Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
• Have previously received amyloid-targeting therapy.
• Active immunization against amyloid-beta.
• Have a centrally read MRI that does not meet study entry criteria.
• Have contraindication to MRI or PET scans.
• Have any contraindication to lumbar puncture.

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 · 42 центра

• TrialSphere Corp — Chandler
• HonorHealth Research Institute — Scottsdale
• Profound Research LLC — Carlsbad
• Irvine Clinical Research — Irvine
• UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla
• Stanford Neuroscience Health Center — Palo Alto
• CenExel Rocky Mountain Clinical Research — Englewood
• Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford
• … и ещё 34 центра

Япония · 18 центров

• Memory Clinic Ochanomizu — Bunkyō City
• Shonan Keiiku Hospital — Fujisawa
• Hyogo Prefectural Harima-Himeji General Medical Center — Himeji
• Inage Neurology and Memory Clinic — Inage
• Nippon Medical School Musashi Kosugi Hospital — Kawasaki
• St. Marianna University Hospital — Kawasaki
• Kobe University Hospital — Kobe
• Juntendo Tokyo Koto Geriatric Medical Center — Kōtoku
• … и ещё 10 центров

Тайвань · 6 центров

• Taipei Medical University Shuang Ho Hospital — New Taipei City
• New Taipei Municipal TuCheng Hospital — New Taipei City
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei
• Chang Gung Medical Foundation-Linkou Branch — Taoyuan

South Korea · 5 центров

• Gangnam Severance Hospital, Yonsei University Health System — Gangnam-gu
• Inha University Hospital — Incheon
• Hanyang University Seoul Hospital — Seoul
• Konkuk University Medical Center — Seoul
• Ewha Womans University Mokdong Hospital — Seoul

Идентификаторы

NCT: NCT07589595 · 27790 · I5T-MC-AACV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗