Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease

Completed · Not applicable

Conditions studied: Alzheimer Disease, Alzheimer Disease, Late Onset

In brief

The purpose of this study is to determine the safety and initial efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild/moderate Alzheimer's Disease. Throughout a 2-month treatment period, patients will be evaluated for cognitive performance, brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF) markers for Alzheimer's Disease. Since all patients will receive TEMT, each patient's baseline measurements will serve as their own control for any treatment effects.

Key facts

Study ID

NCT02958930

Run by

NeuroEM Therapeutics, Inc.

People needed

8

Starts

2017-10-01

Expected to finish

2019-01-11

Last updated by the study team

2019-04-23

Who can join

Age: 63 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
• MMSE score 16 to 26
• Physical clearance for study participation as evaluated by the clinician.
• Caregiver (spouse, family member, etc.) who agrees to and is capable of taking care and being responsible for the participation of the patient in the study (keeping a diary of health measures they collect on the patient at home, logging the patient's condition daily, and assuming responsibility for administering daily in-home treatment). Caregiver to have non-impaired mental abilities and normal motor skills, as determined by the investigators at screening. The definition of caregivers for this study is adults providing unpaid care to relatives or friends to help them take care of themselves in such activities as managing finances, shopping, preparing meals, and going to doctor appointments.
• Agreement to participate in approximately 10 weeks during the study.
• Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
• Fluent in English
• Minimum of 8th grade education
• Head circumference between 53 - 58 cm (to minimize variability in head antenna locations)
• If medicated for AD, then use of cholinesterase inhibitors and/or memantine for at least 3 months, on stable dose for at least 60 days prior to screening, and maintenance on that dose for the period of this study.
• All other non-AD medications must be stable for a period of 4 weeks prior to screening

You may not qualify if…

• CDR Global Score of 0, 0.5 or 3
• Severe agitation
• Mental retardation
• Unstable medical condition
• Use of benzodiazepines or barbiturates 2 weeks prior to screening
• Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment and no history of immunotherapy research participation
• History of Epileptic Seizures or Epilepsy
• Patients with major depression (not controlled with medication), bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past). The investigator will obtain this information from available patient medical records, history provided by the patient and caregiver, interview, and neurological exam.
• Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
• Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
• Patients with vitamin B12 deficiency, abnormal thyroid function, or personal history of either any clinically defined medical disorder or any clinically defined neurological/psychiatric disorder (other than AD), including (but not limited to):, stroke, brain lesions, , cerebrovascular condition, other neurodegenerative disease, significant head trauma (loss of consciousness greater than half an hour, or related anterograde amnesia), multiple sclerosis; or personal history of previous neurosurgery or brain radiation
• Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam.
• Patients with demonstrated brain micro-hemorrhages at screening
• Patients with a score of 4 or higher on the Hachinski Test
• Patients with a score of 2 or less on the Global Deterioration Scale
• Patients with hypertension that is unresponsive to anti-hypertensive medications
• Patients with a history of migraine headaches occurring more than once a month
• Patients with a history of cancer within the last 3 years
• Patients chronically taking anticoagulants or anti-platelets (at discretion of Principal Investigator)
• Pregnant women and women who have the ability to become pregnant
• Patients with compressed hair thickness of more than 5mm (which could increase distance between head antennas and the scalp).
• Cardiac pacemakers
• Implanted medication pumps
• Intracardiac lines
• Significant heart disease

Where it is running

• Byrd Alzheimer's Institute, University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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