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
Verified date | April 2019 |
Source | NeuroEM Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | January 11, 2019 |
Est. primary completion date | January 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 63 Years and older |
Eligibility |
Inclusion Criteria: - 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). - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Byrd Alzheimer's Institute, University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
NeuroEM Therapeutics, Inc. | Byrd Alzheimer's Institute, University of South Florida, Invicro, Boston, Left Coast Engineering, Escondido, University Diagnostic Institute, Tampa |
United States,
Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses ß-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. — View Citation
Arendash 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. — View Citation
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. Review. — View Citation
Arendash 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. Review. — View Citation
Dragicevic 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. — View Citation
Mori 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ADAS-Cog | ADAS-Cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's-related clinical trials. | Change from baseline ADAS-Cog at 2 months | |
Secondary | FDG-PET | FDG-PET scanning is used to determine brain energy metabolism/utilization | Change from baseline FDG-PET at 2 months | |
Secondary | Resting state fMRI | rsfMRI is an MRI scan used to evaluate brain functional connectivity | Change from baseline rsfMRI at 2 months | |
Secondary | Diffusion Tensor Imaging (DTI) | DTI is an MRI scan used to evaluate brain functional connectivity | Change from baseline DTI at 2 months | |
Secondary | Susceptibility-Weighted Imaging (SWI) | SWI is an MRI scan used to determine any brain microhemorrhages or tumors | Change from Baseline SWI at 2 months | |
Secondary | Blood and CSF beta-amyloid levels | Blood and CSF will be analyzed for the toxic protein beta-amyloid | Change from Baseline beta-amyloid levels at 2 months | |
Secondary | Blood and CSF tau levels | Blood and CSF will be analyzed for the toxic protein tau | Change from Baseline tau levels at 2 months | |
Secondary | Blood and CSF markers of immune function | Blood and CSF will be analyzed for pro- and anti-inflammatory cytokines (same measure units) | Change from Baseline pro- and anti-inflammatory cytokine levels at 2 months | |
Secondary | Blood and CSF markers of oxidative stress | Blood and CSF will be analyzed for oxidative markers (same measure units) | Change from Baseline oxidative stress levels at 2 months | |
Secondary | Adverse Event Assessment | AEA will be the primary safety outcome measure | Change from Baseline Adverse Event Assessment at 2 months | |
Secondary | ADCS-ADL score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline ADCS-ADL score at 2 months | |
Secondary | MMSE score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline MMSE score at 2 months | |
Secondary | Global Deterioration score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Global Deterioration score at 2 months | |
Secondary | Hachinski score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Hachinski score at 2 months | |
Secondary | Rey AVLT score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Rey AVLT score at 2 months | |
Secondary | Trails A & B score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Trails A & B scores at 2 months | |
Secondary | Digit span score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Digit span score at 2 months | |
Secondary | Clock draw score | This is a secondary cognitive outcome to assess effects of treatment on cognition. | Change from Baseline Clock draw score at 2 months |
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