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

NCT07222605 | Enrolling By Invitation FDA Device

• 1 other identifier: CareONE-002
• Study Type: interventional
• Target: 1,000
• 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 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.

Conditions

Alzheimer Disease; Parkinson Disease; Frontotemporal Dementia; Cortico Basal Degeneration; Posterior Cortical Atrophy (PCA); Neurological Diseases or Conditions; Dementia

Keywords

Alzheimer; Dementia; Cognitive Impairment; FDA Breakthrough Device

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 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• eQ8Health Corporation d/b/a CareONE Concierge: lead
• NeuroEM Therapeutics, Inc.: collaborator

Study Sites (1)

CareONE Concierge

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Frontotemporal Dementia; Corticobasal Degeneration; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders

Study Officials

• Jason M Cavolina, PharmD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

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: July 8, 2025
• First Posted: October 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Dec 2025 for each contiguous month through the end of the first phase of the study which is Dec 2026.
• Access Criteria: The Principal Investigator (Edward Goodwin, PharmD) of NeuroEM will be the recipient of IPD

Locations

US (1)