Меню
Идёт набор NCT06862557

Pulsed Electromagnetic Field Treatment With Dementia Patients

Без фазы С лечением Alzheimer's Disease Lewy Body Dementia Vascular Dementia

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: ECHS AD Device.
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia. Базовые параметры: 50 лет — 100 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study

Обзор

An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.

Вмешательства

  • Устройство ECHS AD Device
    Pulsed electromagnetic therapy device

Первичные конечные точки

  • The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [Срок оценки: Change between day 0, and 45, 90, 135, 180 days]
Вторичные конечные точки (5)
  • Mini-Mental Status Exam (MMSE) [Срок оценки: Change between day 0, and 45, 90, 135, 180 days]
  • Quality of Life Scale [Срок оценки: Change between day 0, and 45, 90, 135, 180 days]
  • Global Deterioration questionnaire [Срок оценки: Change between day 0, and 45, 90, 135, 180 days]
  • Side-Effects Questionnaire [Срок оценки: Change between day 0, and 45, 90, 135, 180 days]
  • Clinical Dementia Rating (CDR) sum of boxes (CDR-SB) [Срок оценки: Change between day 0, and 90, 180 days]

Критерии участия

Критерии включения

1\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.

3\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician

Критерии исключения

  • The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
  • The patient does not have a study partner who would be available for interview
  • History of epileptic seizures or epilepsy
  • Has Frontotemporal Dementia
  • Currently taking medication that lowers the seizure threshold, excluding blood thinners
  • Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit).
  • Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
  • Severe agitation that would interfere with study procedures
  • Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
  • Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of >1 week hospitalization) within 4 weeks
  • Head anatomy that interferes with the fit of the treatment device
  • Participation in another clinical trial within the previous 30 days
  • Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
  • Criteria to exclude participants from the blood draw study:

Any condition that may significantly increase risks associated with blood draws

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 · 1 центр
  • University of Miami — Boca Raton

Идентификаторы

NCT: NCT06862557 · HM004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗