Alzheimer DiseaseNCT02958930
Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease
A study testing MemorEM 1000 in people with Alzheimer Disease and Alzheimer Disease, Late Onset, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 63 years and older
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease, Late Onset
- What is being tested?
- MemorEM 1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 11 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 63 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
- Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment and no history of immunotherapy research participation
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Byrd Alzheimer's Institute, University of South Florida
Tampa, Florida, 33613
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Alzheimer Disease, Late Onset
- Being tested
- MemorEM 1000
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemorEM 1000Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TEMT Treatment | Experimental | Patients in this arm will receive Transcranial Electromagnetic Treatment (TEMT) twice daily for a two-month treatment period utilizing the MemorEM 1000 head device. Receives: Device: MemorEM 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog
ADAS-Cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's-related clinical trials.
Measured: Change from baseline ADAS-Cog at 2 months
Secondary outcomes (17)
FDG-PET
FDG-PET scanning is used to determine brain energy metabolism/utilization
Measured: Change from baseline FDG-PET at 2 months
Resting state fMRI
rsfMRI is an MRI scan used to evaluate brain functional connectivity
Measured: Change from baseline rsfMRI at 2 months
Diffusion Tensor Imaging (DTI)
DTI is an MRI scan used to evaluate brain functional connectivity
Measured: Change from baseline DTI at 2 months
Susceptibility-Weighted Imaging (SWI)
SWI is an MRI scan used to determine any brain microhemorrhages or tumors
Measured: Change from Baseline SWI at 2 months
Blood and CSF beta-amyloid levels
Blood and CSF will be analyzed for the toxic protein beta-amyloid
Measured: Change from Baseline beta-amyloid levels at 2 months
Blood and CSF tau levels
Blood and CSF will be analyzed for the toxic protein tau
Measured: Change from Baseline tau levels at 2 months
Blood and CSF markers of immune function
Blood and CSF will be analyzed for pro- and anti-inflammatory cytokines (same measure units)
Measured: Change from Baseline pro- and anti-inflammatory cytokine levels at 2 months
Blood and CSF markers of oxidative stress
Blood and CSF will be analyzed for oxidative markers (same measure units)
Measured: Change from Baseline oxidative stress levels at 2 months
Adverse Event Assessment
AEA will be the primary safety outcome measure
Measured: Change from Baseline Adverse Event Assessment at 2 months
ADCS-ADL score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline ADCS-ADL score at 2 months
MMSE score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline MMSE score at 2 months
Global Deterioration score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Global Deterioration score at 2 months
Hachinski score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Hachinski score at 2 months
Rey AVLT score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Rey AVLT score at 2 months
Trails A & B score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Trails A & B scores at 2 months
Digit span score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Digit span score at 2 months
Clock draw score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Change from Baseline Clock draw score at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Oct 2017
- Primary completion4 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroEM Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida, University Diagnostic Institute, Tampa, Invicro, Boston, Left Coast Engineering, Escondido
- Responsible party
- Sponsor
- Investigators
- Amanda Smith, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958930
- Sponsor's protocol ID
- NeuroEM-001
- Other IDs
- EM 1000-1
- Status last verified
- Apr 2019
- First submitted
- 1 Nov 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not anticipated that IPD will be shared with other researchers
Publications
Arendash GW. Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. J Alzheimers Dis. 2016 May 30;53(3):753-71. doi: 10.3233/JAD-160165.
PubMed 27258417Arendash GW. Transcranial electromagnetic treatment against Alzheimer's disease: why it has the potential to trump Alzheimer's disease drug development. J Alzheimers Dis. 2012;32(2):243-66. doi: 10.3233/JAD-2012-120943.
PubMed 22810103Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses beta-amyloid deposition, modifies cerebral blood flow, and provides selected cognitive benefit. PLoS One. 2012;7(4):e35751. doi: 10.1371/journal.pone.0035751. Epub 2012 Apr 25.
PubMed 22558216Dragicevic N, Bradshaw PC, Mamcarz M, Lin X, Wang L, Cao C, Arendash GW. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer's transgenic mice and normal mice: a mechanism for electromagnetic field-induced cognitive benefit? Neuroscience. 2011 Jun 30;185:135-49. doi: 10.1016/j.neuroscience.2011.04.012. Epub 2011 Apr 13.
PubMed 21514369Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, Wang L, Zhang G, Sava V, Tan J, Cao C. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer's disease mice. J Alzheimers Dis. 2010;19(1):191-210. doi: 10.3233/JAD-2010-1228.
PubMed 20061638Mori 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.
Cao C, Abulaban H, Baranowski R, Wang Y, Bai Y, Lin X, Shen N, Zhang X, Arendash GW. Transcranial Electromagnetic Treatment "Rebalances" Blood and Brain Cytokine Levels in Alzheimer's Patients: A New Mechanism for Reversal of Their Cognitive Impairment. Front Aging Neurosci. 2022 May 2;14:829049. doi: 10.3389/fnagi.2022.829049. eCollection 2022.
PubMed 35585867
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02958930
- Acronym / sponsor ID
- NeuroEM-001
- Conditions
- Alzheimer Disease, Alzheimer Disease, Late Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroEM Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida, University Diagnostic Institute, Tampa, Invicro, Boston, Left Coast Engineering, Escondido
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEMT Treatment | Experimental | Device: MemorEM 1000Patients in this arm will receive Transcranial Electromagnetic Treatment (TEMT) twice daily for a two-month treatment period utilizing the MemorEM 1000 head device. |
Who may qualify
- Ages
- 63 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemorEM 1000The 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. | Device | TEMT Treatment |
Primary outcome
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.
17 secondary outcomes
FDG-PET
Time frame: Change from baseline FDG-PET at 2 months
Resting state fMRI
Time frame: Change from baseline rsfMRI at 2 months
Diffusion Tensor Imaging (DTI)
Time frame: Change from baseline DTI at 2 months
Susceptibility-Weighted Imaging (SWI)
Time frame: Change from Baseline SWI at 2 months
Blood and CSF beta-amyloid levels
Time frame: Change from Baseline beta-amyloid levels at 2 months
Blood and CSF tau levels
Time frame: Change from Baseline tau levels at 2 months
Blood and CSF markers of immune function
Time frame: Change from Baseline pro- and anti-inflammatory cytokine levels at 2 months
Blood and CSF markers of oxidative stress
Time frame: Change from Baseline oxidative stress levels at 2 months
Adverse Event Assessment
Time frame: Change from Baseline Adverse Event Assessment at 2 months
ADCS-ADL score
Time frame: Change from Baseline ADCS-ADL score at 2 months
MMSE score
Time frame: Change from Baseline MMSE score at 2 months
Global Deterioration score
Time frame: Change from Baseline Global Deterioration score at 2 months
Hachinski score
Time frame: Change from Baseline Hachinski score at 2 months
Rey AVLT score
Time frame: Change from Baseline Rey AVLT score at 2 months
Trails A & B score
Time frame: Change from Baseline Trails A & B scores at 2 months
Digit span score
Time frame: Change from Baseline Digit span score at 2 months
Clock draw score
Time frame: Change from Baseline Clock draw score at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 27258417Arendash GW. Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. J Alzheimers Dis. 2016 May 30;53(3):753-71. doi: 10.3233/JAD-160165.
- Background: PubMed 22810103Arendash GW. Transcranial electromagnetic treatment against Alzheimer's disease: why it has the potential to trump Alzheimer's disease drug development. J Alzheimers Dis. 2012;32(2):243-66. doi: 10.3233/JAD-2012-120943.
- Background: PubMed 22558216Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses beta-amyloid deposition, modifies cerebral blood flow, and provides selected cognitive benefit. PLoS One. 2012;7(4):e35751. doi: 10.1371/journal.pone.0035751. Epub 2012 Apr 25.
- Background: PubMed 21514369Dragicevic N, Bradshaw PC, Mamcarz M, Lin X, Wang L, Cao C, Arendash GW. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer's transgenic mice and normal mice: a mechanism for electromagnetic field-induced cognitive benefit? Neuroscience. 2011 Jun 30;185:135-49. doi: 10.1016/j.neuroscience.2011.04.012. Epub 2011 Apr 13.
- Background: PubMed 20061638Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, Wang L, Zhang G, Sava V, Tan J, Cao C. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer's disease mice. J Alzheimers Dis. 2010;19(1):191-210. doi: 10.3233/JAD-2010-1228.
- BackgroundMori 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.
- Derived from this study: PubMed 35585867Cao C, Abulaban H, Baranowski R, Wang Y, Bai Y, Lin X, Shen N, Zhang X, Arendash GW. Transcranial Electromagnetic Treatment "Rebalances" Blood and Brain Cytokine Levels in Alzheimer's Patients: A New Mechanism for Reversal of Their Cognitive Impairment. Front Aging Neurosci. 2022 May 2;14:829049. doi: 10.3389/fnagi.2022.829049. eCollection 2022.
- Website provides additional information regarding this technologyLink provided by the sponsor.
- Individual participant dataSharing planned: No. It is not anticipated that IPD will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Smith, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MemorEM 1000 in people with Alzheimer Disease and Alzheimer Disease, Late Onset, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog (time frame: Change from baseline ADAS-Cog at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958930, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.