A Phase I Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease: Extension Study II
Overview
- Phase
- Phase 1
- Sponsor
- NeuroEM Therapeutics, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Alzheimer's Disease Assessment Scale (ADAS)-cog13 score
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 63 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female age 63+ years
- •Patients diagnosed with mild or moderate stage of Alzheimer's Disease at the beginning of the original treatment study, 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 : By the end of Extension Study I, all subjects except for one had MMSE scores above
- •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 54 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 - 60 cm (to minimize variability in head antenna locations)
Exclusion Criteria
- •Severe agitation
- •Mental retardation
- •Unstable medical condition
- •Use of benzodiazepines or barbiturates 2 weeks prior to screening
- •Pharmacological immunosuppression
- •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 (Diagnostic and Statistic Manual of Mental Disorders (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
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale (ADAS)-cog13 score
Time Frame: Changes from baseline ADAS-cog at two, five, eight, and 12 months into treatment
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)
Secondary Outcomes
- Adverse Event Assessment (Adverse Event Assessment)(Change from baseline Adverse Event Assessment at two, five, eight, and 12 months into treatment.)
- Rey AVLT (Auditory Verbal Learning) score(Changes from baseline Rey AVLT score at two, five, eight, and 12 months into treatment)
- Digit span score(Changes from baseline Digit span score at two, five, eight, and 12 months into treatment)
- (Mini Mental State Examination (MMSE) score(Changes from baseline MMSE score at two, five, eight, and 12 months into treatment)
- Global Deterioration score (GDS)(Changes from baseline GDS score 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)(Changes from baseline at two, five, eight, and 12 months into treatment)
- Trails A & B score(Changes from baseline in Trails A & B scores at two, five, eight, and 12 months into treatment)
- MRI Scan (acquisition only)(Change from baseline at 12 months into treatment)
- Clock draw score(Changes from baseline in clock draw score at two, five, eight, and 12 months into treatment)