Electro Cellular Health Solutions, LLC Dementia & Alzheimer’s Disease Pilot Trial Protocol: Effects of PEMF Treatment on Patients with Mild to Moderate Alzheimer’s Disease in a Randomized, Controlled Pilot Study

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 (NINCDSADRDA) 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 9
• Alcoholism or substance use disorder as defined by 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