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

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.

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Key information

Conditions

Alzheimer's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cortico Basal Degeneration Corticobasal Degeneration Fronto-Temporal Dementia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurological Diseases or Conditions Parkinson Disease Parkinson Disease (PD) Parkinsonian Disorders Posterior Cortical Atrophy (PCA) Synucleinopathies Tauopathies

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroEM Therapeutics

Tampa, Florida, 33602, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MemorEM

Device

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.

Primary outcomes

Patient and caregiver reports on device design and use

Time frame: 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 outcomes

Reports of efficacy in treating a patient's neurological condition

Time frame: 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. We 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.

Sponsors and collaborators

Lead sponsor

NeuroEM Therapeutics, Inc.

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 3, 2025
Registry last updated: Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation