Study of Magnetic Fields to Treat Alzheimer's Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Device: Resonator Device: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Alzheimer's Disease Assessment Scale-Cog (ADAS-cog) [ Time Frame: end of treatment at 12 weeks ] [ Designated as safety issue: No ]
- Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale [ Time Frame: end of treatment at 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Resonator
Treatment with active Resonator device using low level magnetic fields
|
Device: Resonator
Treatment group vs. Placebo group
|
| Placebo Comparator: Placebo |
Device: Placebo
Inactive Resonator Device
|
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Colorado | |
| Mile High Research Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Innovative Research of West Florida | |
| Clearwater, Florida, United States, 33756 | |
| Principal Investigator: | Jack A Klapper, MD | Mile High Research Center |
| Principal Investigator: | Miguel Trevino, MD | Innovative Research of West Florida |
More Information
No publications provided
| Responsible Party: | Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC, Pico-Tesla Magnetic Therapies, LLC |
| ClinicalTrials.gov Identifier: | NCT01313806 History of Changes |
| Other Study ID Numbers: | WIRB 1123661 |
| Study First Received: | March 10, 2011 |
| Last Updated: | May 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by pico-tesla Magnetic Therapies, LLC:
|
dementia memory loss cognitive decline |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013