Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
30 participants
INTERVENTIONAL
2011-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Resonator
Treatment with active Resonator device using low level magnetic fields
Resonator
Treatment group vs. Placebo group
Placebo
Placebo
Inactive Resonator Device
Interventions
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Resonator
Treatment group vs. Placebo group
Placebo
Inactive Resonator Device
Eligibility Criteria
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Inclusion 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
* 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.
55 Years
ALL
No
Sponsors
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pico-tesla Magnetic Therapies, LLC
INDUSTRY
Responsible Party
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Pico-Tesla Magnetic Therapies, LLC
Principal Investigators
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Jack A Klapper, MD
Role: PRINCIPAL_INVESTIGATOR
Mile High Research Center
Miguel Trevino, MD
Role: PRINCIPAL_INVESTIGATOR
Innovative Research of West Florida
Locations
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Mile High Research Center
Denver, Colorado, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Countries
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Other Identifiers
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WIRB 1123661
Identifier Type: -
Identifier Source: org_study_id