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Набор по приглашению NCT06245031

Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

Без фазы С лечением Alzheimer Disease Cognitive Impairment Mild Cognitive Impairment Dementia, Mild

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sensory Stimulation System (GS120) - Active.
Кому может быть актуально
Состояния в реестре: Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia, Mild. Базовые параметры: 50 лет — 92 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Open-Label Extension to a Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (OLE Hope Study, CA-0015)

Обзор

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

Подробное описание

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE).

Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.

Вмешательства

  • Устройство Sensory Stimulation System (GS120) - Active
    Sensory Stimulation System (GS120) - Active settings

Первичные конечные точки

  • Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months [Срок оценки: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]
  • Change from Baseline in a Combined Statistical Test (CST) that creates a composite measure (combining Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) scales into one measure) at 12-Months [Срок оценки: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]
Вторичные конечные точки (1)
  • Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months [Срок оценки: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]

Критерии участия

Критерии включения

  • Randomized and completed 12-months of participation in the Hope Study (CA-0011)
  • Non-childbearing potential or using adequate birth control
  • Available/consenting Study Partner

Критерии исключения

  • Insufficient adherence to treatment in the Hope Study (CA-0011)
  • Living in continuous care nursing home (assisted living permitted)
  • Initiating or ongoing treatment with any of the following during study participation:
  • Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
  • Memantine (Namenda or Namzaric)
  • Nootropic drugs except stable acetylcholinesterase inhibitors

For more information about the Hope Study (CA-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/

or the Hope Study ClinicalTrials.gov posting here: https://clinicaltrials.gov/study/NCT05637801

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 53 центра
  • Barrow Neurological Institute — Phoenix
  • CCT Research - Foothills Research Center — Phoenix
  • Banner Sun Health Research Institute — Sun City
  • Advanced Research Center, Inc — Anaheim
  • ATP Clinical Research, Inc. — Costa Mesa
  • Neurology Center of North Orange County — Fullerton
  • Syrentis Clinical Research — Santa Ana
  • Office of Elizabeth Zarate-Rowell, MD — Seal Beach
  • … и ещё 45 центров

Идентификаторы

NCT: NCT06245031 · CA-0015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗