Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases

Обзор

Primary Objective: The primary objective of this pilot study is to gain voluntary feedback from patients with neurological diseases and their caregivers regarding their experiences using the MemorEM head device. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization. Secondary Objectives: The secondary objective is to note areas of potential improvement in the progression of the subject's neurological disease and identify the potential for the MemorEM to treat neurological diseases other than Alzheimer's disease. We are also interested in Alzheimer's variants like those with ApoE4 alleles (none of the participants in the 8-person pilot were Apo-E4 positive), known mutations causing early onset Alzheimer's, and Posterior Cortical Atrophy. Study Duration: The study will be open-ended with patients continuing use of the MemorEM as they wish or when NeuroEM Therapeutics recalls the device. It is expected but optional that patients will use the devices for approximately two years. Study Design: This study will focus on the "patient experience" of using the MemorEM device over an extended time period. Patients will remain under the care of their physicians and will provide brief descriptions of their device experiences and any suggestions for improvements. This study will not require any interventions other than using the MemorEM device, which was rated as Non-Significant Risk by the Western IRB for the previous pilot trial including two extensions that raised no safety concerns over the two and a half years of treatment. Study Population: The study population will consist of various patients suffering from diagnosed neurological diseases. Patients may be selected from those diagnosed with Alzheimer's disease, Frontotemporal dementia, Posterior cortical atrophy, Corticobasal dementia, Parkinson's disease, and other neurological diseases.

Вмешательства

• Устройство MemorEM
  The MemorEM device delivers 915MHz electromagnetic waves to the head via 8 emitters in a cap worn on the head and powered by a control box and battery worn on the arm.

Первичные конечные точки

• Patient and caregiver reports on device design and use [Срок оценки: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.]

Вторичные конечные точки (1)

• Reports of efficacy in treating a patient's neurological condition [Срок оценки: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.]

Критерии участия

Критерии включения

• Patient diagnosed with a neurological disease involving aggregated proteins such as Alzheimer's and its variants, Parkinson's, Frontotemporal dementia, Amyotrophic lateral sclerosis, Tauopathies, and other related neurological diseases.
• Presence of a caregiver(s) responsible for ensuring treatment compliance and potentially with authority to make medical decisions for the patient if the patient is not competent to make those decisions
• Willing to sign NeuroEM's patient consent form

Критерии исключения

• Patient has uncontrolled: Seizures, Epilepsy, Depression, Bipolar disorder, psychotic disorders, alcoholism or drug addiction
• Presence of metal implants in the head, except for metal dental implants
• Patient has hypertension that is unresponsive to anti-hypertensive medications
• Patient has implanted medication pumps unless cleared by physician
• Patient has significant heart disease, as determined by a physician

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

Другое

Центры проведения

США · 1 центр

• NeuroEM Therapeutics — Tampa

Идентификаторы

NCT: NCT07049341 · NEM-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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