Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

Study Overview
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Brief Summary
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Double-blind, randomized, placebo-controlled pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD pulsed electromagnetic treatment device on disease progression. Enrolled patients will be randomized to active or sham device group. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.

Official Title
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Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Randomized, Controlled Pilot Study

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Device: ECHS AD Device
* Device: ECHS Sham AD Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 to 85 years Patients diagnosed with mild to moderate Alzheimer's Dementia defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al, 2011) At least an eighth grade of educational achievement If female, post-menopausal. MMSE score between 16 and 26 Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity Able and willing to comply with the protocol If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments) Physical clearance for study participation as evaluated by the clinician Exclusion Criteria: The patient lacks capacity to consent to study participation and no surrogate is available to provide consent History of epileptic seizures or epilepsy Currently taking medication that lowers the seizure threshold Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study Severe agitation that would interfere with study procedures Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of >1 week hospitalization) within 4 weeks Head anatomy that interferes with the fit of the treatment device Participation in another clinical trial within the previous 30 days Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind, Randomized, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active ECHS AD device<br>Experimental intervention arm | Device: ECHS AD Device<br>* Pulsed electromagnetic therapy device<br>|
| Sham Comparator: Sham ECHS AD device<br>Sham intervention arm | Device: ECHS Sham AD Device<br>* Non-functioning electromagnetic therapy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) | Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity. | Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days | 
| Mini-Mental Status Exam (MMSE) | Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity | Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days | 
| Global Deterioration questionnaire | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity | Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days | 
| Quality of Life Scale | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity | Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days |