Transcranial Electromagnetic Treatment Against Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03927040|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Alzheimer Disease, Late Onset||Device: MemorEM 1000||Not Applicable|
The present study is an Open-Label within-patient (single arm) extension study of our Open-Label initial study (EM1000-1) whereby seven of the eight Alzheimer's subjects participating in the initial study agreed to participate. The present study is intended to continue evaluation of the safety and efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild-to-moderate Alzheimer's Disease who had previously participated in the initial Open-Label study. The study duration for each subject is approximately 4 1/2 months, which involves a total of four clinical visits: pre-baseline, baseline, 2-months into treatment, and at treatment completion (4-month into treatment).
This extension study will utilize the same MemorEM 1000 head devices (designated as NSR) as in the initial 2-month treatment study, but will involve daily treatment for a longer four month period. Only one 1-hour treatment will be administered per day rather than the two 1-hour treatments per day administered in the initial 2-month study because: 1) the extension study involves a longer period of treatment, and 2) preliminary results from the initial 2-month study show a strong carry-over effect of treatment on cognitive performance after the 2-month treatment period had been completed (14 days after end of treatment).
Cognitive safety/efficacy will be evaluated using the same battery of cognitive tasks as in the initial study. These include ADAS-cog (primary outcome), and secondary cognitive outcomes of Rey AVLT, MMSE, ADCS-ADL, Digit span, Trails A & B, and clock draw tasks. Additional secondary outcomes involve analysis of blood and CSF (collected at baseline, 2-months and/or 4-months into treatment) for various beta-amyloid and tau protein species. As another secondary outcome, safety of TEMT will be monitored by regular Adverse Events Assessment, physiologic monitoring, and patient daily diaries maintained by the caregiver.
Expected Results: The investigators expect that 4-months of once-daily TEMT will not present any significant sides effects or safety issues to the seven subjects who were initially provided the same treatment twice-daily for 2-months. The investigators further expect that cognitive measures will be stable and/or improve by the end of the the treatment period. In addition, changes in blood/CSF levels of various beta-amyloid and tau species are anticipated that reflect the mechanisms of TEMT action.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study Investigating the Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||February 5, 2020|
|Estimated Study Completion Date :||March 30, 2020|
Experimental: TEMT Administration
Subjects in this arm will received Transcranial Electromagnetic Treatment (TEMT) once daily for a 4-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 emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment.
- ADAS-cog score [ Time Frame: Change from baseline ADAS-cog at two and four months into treatment ]ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials.
- Levels of Blood and CSF Alzheimer's markers [ Time Frame: Changes from baseline at two and four months into treatment ]Blood and CSF will be analyzed for beta-amyloid and tau species
- Adverse Event Assessment [ Time Frame: Change from baseline Adverse Event Assessment at two and four months into treatment ]AEA will be the primary safety outcome measures
- Rey AVLT score [ Time Frame: Changes from baseline Rey AVLT score at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition
- Digit span score [ Time Frame: Changes from baseline Digit span score at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition
- MMSE score [ Time Frame: Changes from baseline MMSE score at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition
- Global Deterioration score [ Time Frame: Changes from baseline GDS at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition.
- Trails A & B score [ Time Frame: Changes from baseline in Trails A & B scores at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition
- Clock draw score [ Time Frame: Changes from baseline in Block draw score at two and four months into treatment ]This is a secondary cognitive outcome to assess effects of treatment on cognition
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): NCT03927040
|United States, Florida|
|Byrd Alzheimer's Institute, University of South Florida|
|Tampa, Florida, United States, 33613|
|Principal Investigator:||Amanda Smith, MD||University of South Florida Health / Byrd Alzheimer's Institute|