A Randomized, Single-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer's Disease in Addition to Standard of Care
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33613 |
| Conditions: |
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Alzheimer's Dementia |
| Purpose: |
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The purpose of this study is to determine if low level magnetic fields can help to improve
memory in patients diagnosed with Alzheimer's dementia.
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| Study Summary: |
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The purpose of this pilot study is to determine whether application of magnetic fields
generated by the Resonator result in statistically significant improvements in cognitive
functioning and memory in patients with a diagnosis of Alzheimer's dementia.
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| 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:
- 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.
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| NCT ID: |
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NCT01195389 |
| Primary Contact: |
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Principal Investigator
Amanda Smith, MD
University South Florida Health Byrd Alzheimer's Institute
Amanda Smith, MD
Phone: 813-974-4355
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tampa, Florida 33613
United States
Amanda Smith, MD
Phone: 813-974-4355
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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