NCT01313806WithdrawnNot Applicable
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer"s Disease in Addition to Standard of Care
pico-tesla Magnetic Therapies, LLC4 sites in 1 country30 target enrollmentStarted: September 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
Study Overview
Brief Summary
To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.
Detailed Description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator may improve cognitive functioning and memory in individuals with a diagnosis of Alzheimer"s dementia, as an adjunctive therapy to standard of care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be considered eligible for participation in this clinical study, a subject must satisfy each of the following "Inclusive Conditions" criteria.
- •Current diagnosis of Alzheimer's Disease appropriately documented by the patients physician and/or neurologist
- •Documentation verifying that other generally recognized causes of dementia have been ruled out by prior physician evaluations
- •Mild to Moderate Dementia, as evidenced by a score of not less than 12 nor greater than 26 on the Mini Mental Status Exam (MMSE).
- •Subject is ambulatory
- •A Study Partner who can attend all study visits with the subject. Study Partner being defined as an adult who has at least 10 hours/week of contact with the subject, and can accompany the subject to all testing and treatment study visits.
- •Stable "anti-dementia" medication regimen without significant side effects for at least 3 months, and on stable medication (unrelated to anti-dementia) without significant side effects for at least 1 month; willingness and ability to maintain the stable medication regimen throughout the course of the study.
- •Willingness and ability to present to the testing center for all study evaluations
- •Willingness and ability to present to the treatment center for all study treatments (exposure to the Resonator™)
- •Willingness to maintain stable diet and activity regimen for the duration of the study.
- •Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve cognition and mental functioning
- •Willing and able to abstain from any medications that could affect cognition and mental functioning during the course of the study
- •Male or female.
- •Any ethnic background.
- •Age 55 and older.
- •Exclusion Criteria A subject will be considered ineligible for participation in this clinical study if he or she satisfies any one or more of the following exclusive conditions criteria.
- •Change in anti-dementia medical regimen within 3 months prior to initiation of study.
- •Confirmed diagnosis other non-Alzheimer's type of dementia
- •Significant neurologic or psychiatric illness other than Alzheimer's disease
- •Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
- •Previous surgical interventions involving prosthetics or implants comprised of ferrous metals, or pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- •Reported consumption of more than 14 alcoholic drinks per week.
- •Uncontrolled hypertension.
- •Uncontrolled atrial fibrillation or other uncontrolled arrhythmias, e.g. tachycardia, bradycardia.
- •Uncontrolled seizure disorder.
- •History of seizures or usage of anti-seizure medications that, in the opinion of the investigator, participation in this trial would represent a risk to the subject.
- •Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
Time Frame: end of treatment at 12 weeks
Secondary Outcomes
- Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale(end of treatment at 12 weeks)
Investigators
Study Sites (4)
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