Transcranial Electromagnetic Treatment Against Alzheimer's Disease

NCT03927040 | Completed FDA Device

• 1 other identifier: EM1000-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is an extension of EM 1000-1 wherein subjects who participated in the original study have been given the opportunity to participate in a 4-month extension of TEMT. Seven of the eight subjects in the original EM 1000-1 agreed to participate in this study extension. The time between completion of the initial study's 2-month treatment period and the beginning of this extension study's 4-month treatment period will range from 4 months to 13 months (due to staggered start of treatment in the initial study). This extension study's primary objective is to determine the effects of a follow-up treatment period of 4-months on performance of Alzheimer's Disease (AD) subjects in the same comprehensive array of cognitive tasks they performed in the initial 2-month treatment study. Baseline cognitive performance will be compared to performance at both 2-months into treatment and at the end of the 4-month treatment period. Secondary objectives include analysis of blood and CSF for AD markers and evaluation of safety throughout the treatment period.

Conditions

Alzheimer Disease; Alzheimer Disease, Late Onset

Keywords

Alzheimer's Disease; Transcranial Electromagnetic Treatment; Cognitive Assessment; Alzheimer's markers in blood and CSF

Outcome Measures

Primary Outcomes (1)

• ADAS-cog score

  ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials.

  Change from baseline ADAS-cog at two and four months into treatment

Secondary Outcomes (8)

• Levels of Blood and CSF Alzheimer's markers

  Changes from baseline at two and four months into treatment

• Adverse Event Assessment

  Change from baseline Adverse Event Assessment at two and four months into treatment

• Rey AVLT score

  Changes from baseline Rey AVLT score at two and four months into treatment

• Digit span score

  Changes from baseline Digit span score at two and four months into treatment

• MMSE score

  Changes from baseline MMSE score at two and four months into treatment

Study Arms (1)

TEMT Administration

EXPERIMENTAL

Subjects in this arm will received Transcranial Electromagnetic Treatment (TEMT) once daily for a 4-month treatment period utilizing the MemorEM 1000 head device.

Device: MemorEM 1000

Interventions

MemorEM 1000 DEVICE

The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment.

TEMT Administration

Eligibility Criteria

• Age: 63 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 18 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 - 60 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:

• Severe agitation
• Mental retardation
• Unstable medical condition
• Use of benzodiazepines or barbiturates 2 weeks prior to screening
• Pharmacological immunosuppression
• 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 (more than 5) 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

Sponsors & Collaborators

• NeuroEM Therapeutics, Inc.: lead

Study Sites (1)

Byrd Alzheimer's Institute, University of South Florida

Tampa, Florida, 33613, United States

Location

Related Publications (6)

• Arendash GW. Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. J Alzheimers Dis. 2016 May 30;53(3):753-71. doi: 10.3233/JAD-160165.

  PMID: 27258417 BACKGROUND

• Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses beta-amyloid deposition, modifies cerebral blood flow, and provides selected cognitive benefit. PLoS One. 2012;7(4):e35751. doi: 10.1371/journal.pone.0035751. Epub 2012 Apr 25.

  PMID: 22558216 BACKGROUND

• Arendash GW. Transcranial electromagnetic treatment against Alzheimer's disease: why it has the potential to trump Alzheimer's disease drug development. J Alzheimers Dis. 2012;32(2):243-66. doi: 10.3233/JAD-2012-120943.

  PMID: 22810103 BACKGROUND

• Dragicevic N, Bradshaw PC, Mamcarz M, Lin X, Wang L, Cao C, Arendash GW. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer's transgenic mice and normal mice: a mechanism for electromagnetic field-induced cognitive benefit? Neuroscience. 2011 Jun 30;185:135-49. doi: 10.1016/j.neuroscience.2011.04.012. Epub 2011 Apr 13.

  PMID: 21514369 BACKGROUND

• Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, Wang L, Zhang G, Sava V, Tan J, Cao C. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer's disease mice. J Alzheimers Dis. 2010;19(1):191-210. doi: 10.3233/JAD-2010-1228.

  PMID: 20061638 BACKGROUND

• Mori T, Arendash GW. Electromagnetic field treatment enhances neuronal activity: Linkage to cognitive benefit and therapeutic implications for Alzheimer's Disease. J Alzheimer's Dis and Parkinsonism 2011; 1:102, http://dx.doi.org/10.4172/2161-0460.1000102.

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amanda Smith, MD

  University of South Florida Health / Byrd Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: April 15, 2019
• Primary Completion: October 5, 2020
• Study Completion: October 30, 2020
• Last Updated: May 22, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)