Clinical trial NCT01195389: Safety and Efficacy Study of Magnetic Fields to Treat Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Dementia
Keywords: dementia
memory loss
cognitive decline
Lead sponsor: pico-tesla Magnetic Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
timeFrame: end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health Byrd Alzheimer's Institute
state: Florida
Study officials:
affiliation: University South Florida Health Byrd Alzheimer's Institute
name: Amanda Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: