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

NCT ID: NCT07049341

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-06-30

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 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.

Conditions

Alzheimer's Disease; Fronto-temporal Dementia; Parkinson Disease (PD); Cortico Basal Degeneration; Posterior Cortical Atrophy (PCA); Neurological Diseases or Conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient Experience Arm

Group Type: ACTIVE_COMPARATOR

MemorEM

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroEM Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NeuroEM Therapeutics

Tampa, Florida, United States

Countries

United States

Other Identifiers

NEM-004

Identifier Type: -

Identifier Source: org_study_id