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

NeuroEM Therapeutics

Status

Invitation-only

Conditions

Alzheimer's Disease

Fronto-temporal Dementia

Posterior Cortical Atrophy (PCA)

Cortico Basal Degeneration

Parkinson Disease (PD)

Neurological Diseases or Conditions

Treatments

Device: MemorEM

Study type

Interventional

Funder types

Industry

Identifiers

NCT07049341

NEM-004

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

45 to 100 years old

Volunteers

No Healthy Volunteers

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
Willing to sign NeuroEM's patient consent form

Exclusion criteria

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