Alzheimer Disease Clinical Trial
Official title:
An Open-Label Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease
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.
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.
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