This is a second extension of EM 1000-1 wherein mild/moderate AD subjects who participated in the original study have completed participation in a first extension of 4-months. Most of the eight subjects in the original EM 1000-1 and first extension agreed to participate in this second extension study. The time between completion of the first extension and the second extension is 4 months. This second extension study;'s primary objective is to determine the long-term safety and efficacy of 12 months of daily treatment on performance of these AD subjects in the same comprehensive array of cognitive tasks as they performed in the initial 2-month study and 4-month first extension.Secondary objectives include analysis of blood for AD markers and evaluation of safety throughout the treatment period. Upon completion of this 12-month extension, the period between initial treatment and final treatment will be 2-3 years.
The present study is an Open-Label within-patient (single arm) second extension study of the Open-Label 2-month initial study (EM1000-1) and 4M first extension study, wherein most of the original eight AD subjects agree to participate. This present second extension study is intended to continue evaluation of the safety and efficacy of daily Transcranial Electromagnetic Treatment (TEMT) in patients with mild-to-moderate AD for an additional 12 month period, such that the interval between the initial day of treatment and final day of treatment will be 2-3 years.There will be a total of six clinical visits: pre-baseline, baseline, 2-, 5-, 8-, and 12-months. This second extension study will utilize the same MemorEM devices (designated as NSR and not Food and Drug Administration-regulated) as in the first extension studies, but will involve twice daily treatment for the first two months, followed by once-daily treatment thereafter. Expected Results: The investigators expect that the additional 12 months of daily TEMT will not present any significant side effects or safety issues, as was the case for the initial study and first extension study. The investigators further expect that cognitive measures will be stable and/or improve by the end of the 12M treatment period. In addition, changes in blood/cerebrospinal fluid levels of various beta-amyloid and tau species are anticipated to reflect the primary mechanism of TEMT action -- disaggregation of both A-beta and tau oligomers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The MemorEM device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range to the entire forebrain, 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. Everyday for the 12M treatment period, the subject's caregiver will administer one or two 1-hour treatments (two daily treatments during the first 2M period).
Axiom Clinical Research of Florida
Tampa, Florida, United States
Alzheimer's Disease Assessment Scale (ADAS)-cog13 score
ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials. Upper limit is 85 (poor performance) and lower limit is zero (best performance)
Time frame: Changes from baseline ADAS-cog at two, five, eight, and 12 months into treatment
Blood (plasma) levels of beta-amyloid1-40 and 1-42, total tau (t-tau), and phospho-tau (p-tau)
Blood will be analyzed for beta-amyloid and tau species via specific monoclonal antibody kits
Time frame: Changes from baseline at two, five, eight, and 12 months into treatment
Adverse Event Assessment (Adverse Event Assessment)
AEA will be the primary safety outcome measure
Time frame: Change from baseline Adverse Event Assessment at two, five, eight, and 12 months into treatment.
Rey AVLT (Auditory Verbal Learning) score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Time frame: Changes from baseline Rey AVLT score at two, five, eight, and 12 months into treatment
Digit span score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Time frame: Changes from baseline Digit span score at two, five, eight, and 12 months into treatment
(Mini Mental State Examination (MMSE) score
This is a secondary cognitive outcome to assess effects of treatment on cognition; maximum (best) score is 30 and minimum (worse) score is zero
Time frame: Changes from baseline MMSE score at two, five, eight, and 12 months into treatment
Global Deterioration score (GDS)
This is a secondary cognitive outcome to assess effects of treatment on cognition
Time frame: Changes from baseline GDS score at two, five, eight, and 12 months into treatment
Trails A & B score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Time frame: Changes from baseline in Trails A & B scores at two, five, eight, and 12 months into treatment
Clock draw score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Time frame: Changes from baseline in clock draw score at two, five, eight, and 12 months into treatment
MRI Scan (acquisition only)
This is a safety outcome to assess any brain consequences of treatment
Time frame: Change from baseline at 12 months into treatment
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