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Trial record 1 of 1 for:    02958930
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Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02958930
First Posted: November 8, 2016
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Byrd Alzheimer's Institute, University of South Florida
University Diagnostic Institute, Tampa
Arizona State University
Information provided by (Responsible Party):
NeuroEM Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease Alzheimer Disease, Late Onset Device: MemorEM 1000 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by NeuroEM Therapeutics, Inc.:

Primary Outcome Measures:
  • ADAS-Cog [ Time Frame: Change from baseline ADAS-Cog at 2 months ]
    ADAS-Cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's-related clinical trials.


Secondary Outcome Measures:
  • FDG-PET [ Time Frame: Change from baseline FDG-PET at 2 months ]
    FDG-PET scanning is used to determine brain energy metabolism/utilization

  • Resting state fMRI [ Time Frame: Change from baseline rsfMRI at 2 months ]
    rsfMRI is an MRI scan used to evaluate brain functional connectivity

  • Diffusion Tensor Imaging (DTI) [ Time Frame: Change from baseline DTI at 2 months ]
    DTI is an MRI scan used to evaluate brain functional connectivity

  • Susceptibility-Weighted Imaging (SWI) [ Time Frame: Change from Baseline SWI at 2 months ]
    SWI is an MRI scan used to determine any brain microhemorrhages or tumors

  • Blood and CSF beta-amyloid levels [ Time Frame: Change from Baseline beta-amyloid levels at 2 months ]
    Blood and CSF will be analyzed for the toxic protein beta-amyloid

  • Blood and CSF tau levels [ Time Frame: Change from Baseline tau levels at 2 months ]
    Blood and CSF will be analyzed for the toxic protein tau

  • Blood and CSF markers of immune function [ Time Frame: Change from Baseline pro- and anti-inflammatory cytokine levels at 2 months ]
    Blood and CSF will be analyzed for pro- and anti-inflammatory cytokines (same measure units)

  • Blood and CSF markers of oxidative stress [ Time Frame: Change from Baseline oxidative stress levels at 2 months ]
    Blood and CSF will be analyzed for oxidative markers (same measure units)

  • Adverse Event Assessment [ Time Frame: Change from Baseline Adverse Event Assessment at 2 months ]
    AEA will be the primary safety outcome measure

  • ADCS-ADL score [ Time Frame: Change from Baseline ADCS-ADL score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • MMSE score [ Time Frame: Change from Baseline MMSE score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Global Deterioration score [ Time Frame: Change from Baseline Global Deterioration score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Hachinski score [ Time Frame: Change from Baseline Hachinski score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Rey AVLT score [ Time Frame: Change from Baseline Rey AVLT score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Trails A & B score [ Time Frame: Change from Baseline Trails A & B scores at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Digit span score [ Time Frame: Change from Baseline Digit span score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.

  • Clock draw score [ Time Frame: Change from Baseline Clock draw score at 2 months ]
    This is a secondary cognitive outcome to assess effects of treatment on cognition.


Enrollment: 12
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEMT Treatment
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
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.

Detailed Description:

There is currently no effective therapeutic to stabilize or reverse the cognitive impairment of Alzheimer's Disease (AD) and related dementias. Clinical trials with drugs have been unsuccessful because the wrong therapeutic target/species were selected, because drugs have great difficulty traversing the blood-brain barrier and getting into neurons, and/or because drugs largely have only a single mechanism of action. Since ever-increasing experimental evidence indicates that the toxic forms of both beta-amyloid and tau are the soluble "oligomeric" species of these two proteins, therapeutics to disaggregate these oligomers within neurons represent perhaps the best chance for attaining cognitive benefit in AD patients.

Pre-clinical studies performed by the Sponsor and his collaborators have demonstrated that AD transgenic mice treated daily with electromagnetic waves in the radiofrequency (RF) range are protected from cognitive impairment or show a reversal of pre-existing cognitive impairment. These cognitive benefits appear to be due primarily to two complimentary mechanisms: 1) disaggregation of toxic protein oligomers within neurons, and 2) mitochondrial enhancement to increase energy metabolism. Moreover, no deleterious effects of treatment over many months have been observed in these pre-clinical studies.

In order to provide similar treatment to mild/moderate Alzheimer's patients clinically, NeuroEM Therapeutics has developed a unique head device that provides electromagnetic (RF) treatment to the entire human forebrain at levels similar to those that provided cognitive benefits in pre-clinical studies. Using the MemorEM 1000 head device in the present Phase I trial, AD patients receive twice daily 1-hour treatments in-home, as administered by their caregiver. The device allows for the patient to have complete mobility for moving throughout their home.

A comprehensive array of markers will be analyzed both during and following the 2-month treatment period, with baseline (pre-treatment) values serving as controls. Cognitive safety and efficacy will be evaluated using a variety of cognitive assessments including ADAS-cog (Primary), and secondary cognitive measures including ADCS-ADL, Rey AVLT, Trails A & B, Digit span, and clock draw tasks. Treatment effects on brain energy metabolism will be determine by FDG-PET scans, while treatment effects on brain functional connectivity will be determined through both resting state MRI and Diffusion Tensor Imaging. Also being assessed are the effects of treatment on various beta-amyloid and tau protein species (e.g., monomers, oligomers) in both blood and CSF. Safety of the treatment will be monitored by regular Adverse Events Assessment, physiologic monitoring, and patient daily diaries maintained by the caregiver.

Expected Results: The investigators expect that 2-months of daily electromagnetic (RF) treatment will not present any significant side effects or safety issues. The investigators further expect that cognitive measures will be stable and/or improve by the end of treatment. In addition, the investigators anticipate that brain functional connectivity may be improved and that enhanced brain metabolism (FDG-PET) will occur. Changes in blood/CSF levels of various beta-amyloid and tau species are also anticipated.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   63 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958930


Locations
United States, Florida
Byrd Alzheimer's Institute, University of South Florida
Tampa, Florida, United States, 33613
Sponsors and Collaborators
NeuroEM Therapeutics, Inc.
Byrd Alzheimer's Institute, University of South Florida
University Diagnostic Institute, Tampa
Arizona State University
Investigators
Principal Investigator: Amanda Smith, MD Byrd Alzheimer's Institute, University of South Florida
  More Information

Additional Information:
Publications:
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.

Responsible Party: NeuroEM Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02958930     History of Changes
Other Study ID Numbers: NeuroEM-001
EM 1000-1 ( Other Identifier: TBA )
First Submitted: November 1, 2016
First Posted: November 8, 2016
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not anticipated that IPD will be shared with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Late Onset Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes