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

NCT02958930 | Completed

• 2 other identifiers: NeuroEM-001EM 1000-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Alzheimer Disease, Late Onset

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog

  ADAS-Cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's-related clinical trials.

  Change from baseline ADAS-Cog at 2 months

Secondary Outcomes (17)

• FDG-PET

  Change from baseline FDG-PET at 2 months

• Resting state fMRI

  Change from baseline rsfMRI at 2 months

• Diffusion Tensor Imaging (DTI)

  Change from baseline DTI at 2 months

• Susceptibility-Weighted Imaging (SWI)

  Change from Baseline SWI at 2 months

• Blood and CSF beta-amyloid levels

  Change from Baseline beta-amyloid levels at 2 months

Study Arms (1)

TEMT Treatment

EXPERIMENTAL

Patients in this arm will receive Transcranial Electromagnetic Treatment (TEMT) twice daily for a two-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 antennas in the head cap worn by the subject. The device provides global RF treatment to the entire forebrain, including deep brain areas. For each of the 60 days of in-home treatment, two one-hour treatment will be given (early morning and late afternoon). Each treatment will be administered by the patient's caregiver, who will position the device on the patient's head and monitor treatment.

TEMT Treatment

Eligibility Criteria

• Age: 63 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 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

Sponsors & Collaborators

• NeuroEM Therapeutics, Inc.: lead
• Byrd Alzheimer's Institute, University of South Florida: collaborator
• University Diagnostic Institute, Tampa: collaborator
• Invicro, Boston: collaborator
• Left Coast Engineering, Escondido: collaborator

Study Sites (1)

Byrd Alzheimer's Institute, University of South Florida

Tampa, Florida, 33613, United States

Location

Related Publications (7)

• 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. 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

• 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

• 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: Vol. 1:102, http://dx.doi.org/10.4172/2161-0460.1000102.

  BACKGROUND

• Cao C, Abulaban H, Baranowski R, Wang Y, Bai Y, Lin X, Shen N, Zhang X, Arendash GW. Transcranial Electromagnetic Treatment "Rebalances" Blood and Brain Cytokine Levels in Alzheimer's Patients: A New Mechanism for Reversal of Their Cognitive Impairment. Front Aging Neurosci. 2022 May 2;14:829049. doi: 10.3389/fnagi.2022.829049. eCollection 2022.

  PMID: 35585867 DERIVED

Related Links

• Website provides additional information regarding this technology

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

  Byrd Alzheimer's Institute, University of South Florida

  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

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 8, 2016
• Study Start: October 1, 2017
• Primary Completion: January 4, 2019
• Study Completion: January 11, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)