Alzheimer Disease, Cortico Basal Degeneration, Dementia, Frontotemporal Dementia, Neurological Diseases or Conditions, Parkinson Disease, Posterior Cortical Atrophy (PCA)
Conditions
Keywords
Alzheimer, Dementia, Cognitive Impairment, FDA Breakthrough Device
Brief summary
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 Objective: 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. The investigators 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.
Detailed description
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.
Interventions
DEVICEMemorEM
The MemorEM device delivers 915MHz electromagnetic waves to the head via emitters in a cap worn on the head and powered by a control box and battery worn on the arm.
Sponsors
eQ8Health Corporation d/b/a CareONE Concierge
NeuroEM Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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. * A statement from each patient's physician that indicates the patient has the ability to understand and consent on their own AND they have the willingness to sign CareONE's patient consent.
Exclusion criteria
* Patient has Seizures, Epilepsy, uncontrolled Depression, uncontrolled 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and caregiver reports on device design and use | Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years. | 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 will be gathered via a monthly survey. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reports of efficacy in treating a patient's neurological condition | Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years. | 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. The investigators are also interested in Alzheimer's variants like those with ApoE4 alleles, known mutations causing early onset Alzheimer's, and Posterior Cortical Atrophy. The monthly survey contains questions designed to identify changes in cognition, mood, physical symptoms, activities of daily living, and capture any narrative information provided by patient or caregiver. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason M Cavolina, PharmD
Principal Investigator
Outcome results
None listed