Research Study for Patients With Neurological Diseases Which Evaluates the Patient Experience of the MemorEM Device (MemorEM)

Research Study 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 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Dementia; Alzheimer Disease; Frontotemporal Dementia; Neurological Diseases or Conditions; Posterior Cortical Atrophy (PCA); Cortico Basal Degeneration
• Intervention / Treatment: Device: MemorEM

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • CareONE Concierge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient Experience Arm	Device: MemorEM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reports of efficacy in treating a patient's neurological condition	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.	Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.

Collaborators and Investigators

• Sponsor: eQ8Health Corporation d/b/a CareONE Concierge
• Collaborators: NeuroEM Therapeutics, Inc.
• Investigators: Principal Investigator: Jason M Cavolina, PharmD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Dementia; Alzheimer; FDA Breakthrough Device
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Frontotemporal Lobar Degeneration; Nutritional and Metabolic Diseases; Corticobasal Degeneration; Cognitive Dysfunction; Alzheimer Disease; Parkinson Disease; Dementia; Frontotemporal Dementia
• Other Study ID Numbers: CareONE-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share all study results (de-identified) with study collaborator (NeuroEM)
• IPD Sharing Time Frame: Dec 2025 for each contiguous month through the end of the first phase of the study which is Dec 2026.
• IPD Sharing Access Criteria: The Principal Investigator (Edward Goodwin, PharmD) of NeuroEM will be the recipient of IPD
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes