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

NCT07049341 | Enrolling By Invitation FDA Device

• 1 other identifier: NEM-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Patient and caregiver reports on device design and use

  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.

  Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Patient Experience Arm

ACTIVE COMPARATOR

Device: MemorEM

Interventions

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.

Patient Experience Arm

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroEM Therapeutics, Inc.: lead

Study Sites (1)

NeuroEM Therapeutics

Tampa, Florida, 33602, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Corticobasal Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 3, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)