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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Phase 1 Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease

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.

Detailed Summary:

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
Sponsor: NeuroEM Therapeutics, Inc.

Current Primary Outcome: ADAS-Cog [ Time Frame: Change from baseline ADAS-Cog at 2 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: NeuroEM Therapeutics, Inc.

Dates:
Date Received: November 1, 2016
Date Started: November 2016
Date Completion: March 2017
Last Updated: November 7, 2016
Last Verified: November 2016