[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07049341":3,"trial-entities:NCT07049341":80,"trial-summary:NCT07049341":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":77,"references":78,"see_also_links":79},"NCT07049341","NEM-004","Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases","ENROLLING_BY_INVITATION","2028-06","2025-07","2025-08-05","2025-07-31","NeuroEM Therapeutics, Inc.","INDUSTRY",null,"Primary Objective:\n\nThe 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.\n\nSecondary Objectives:\n\nThe 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.\n\nStudy Duration:\n\nThe 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.\n\nStudy Design:\n\nThis 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.\n\nStudy Population:\n\nThe 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.",[17,18,19,20,21,22],"Alzheimer's Disease","Fronto-temporal Dementia","Parkinson Disease (PD)","Cortico Basal Degeneration","Posterior Cortical Atrophy (PCA)","Neurological Diseases or Conditions",[],"INTERVENTIONAL","OTHER",[27],"NA",{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","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.",[37],"Patient Experience Arm",[39],{"measure":40,"description":41,"timeFrame":42},"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.",[44],{"measure":45,"description":46,"timeFrame":42},"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. 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.","ALL","45 Years","100 Years",false,{"inclusion":52,"exclusion":56,"raw_text":62},[53,54,55],"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",[57,58,59,60,61],"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","Inclusion Criteria:\n\n* 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.\n* 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\n* Willing to sign NeuroEM's patient consent form\n\nExclusion Criteria:\n\n* Patient has uncontrolled: Seizures, Epilepsy, Depression, Bipolar disorder, psychotic disorders, alcoholism or drug addiction\n* Presence of metal implants in the head, except for metal dental implants\n* Patient has hypertension that is unresponsive to anti-hypertensive medications\n* Patient has implanted medication pumps unless cleared by physician\n* Patient has significant heart disease, as determined by a physician",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"NeuroEM Therapeutics","Tampa","Florida","33602","United States",{"lat":74,"lon":75},27.94752,-82.45843,[],[],[],[],{"nct_id":4,"conditions":81,"biomarkers":90},[82,83,84,85,86,87,88,89],"Alzheimer's Disease","Amyotrophic Lateral Sclerosis","Corticobasal Degeneration","Frontotemporal Dementia","Parkinson Disease","Posterior cortical atrophy syndrome","Tauopathies","Urinary System Disorder",[],{"nct_id":4,"found":50,"summary":14,"prompt_version":14}]