Study of Magnetic Fields to Treat Alzheimer's Disease
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.
Key facts
- Study ID
- NCT01313806
- Run by
- pico-tesla Magnetic Therapies, LLC
- People needed
- 30
- Starts
- 2011-09-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2011-05-30
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Mile High Research Center — Denver, Colorado, United States
- Innovative Research of West Florida — Clearwater, Florida, United States
Full record on ClinicalTrials.gov
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