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Study of Magnetic Fields to Treat Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resonator
Placebo
Sponsored by
pico-tesla Magnetic Therapies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring dementia, memory loss, cognitive decline

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mile High Research Center
  • Innovative Research of West Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resonator

Placebo

Arm Description

Treatment with active Resonator device using low level magnetic fields

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)

Secondary Outcome Measures

Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale

Full Information

First Posted
March 10, 2011
Last Updated
May 27, 2011
Sponsor
pico-tesla Magnetic Therapies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01313806
Brief Title
Study of Magnetic Fields to Treat Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
pico-tesla Magnetic Therapies, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
dementia, memory loss, cognitive decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resonator
Arm Type
Active Comparator
Arm Description
Treatment with active Resonator device using low level magnetic fields
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Resonator
Intervention Description
Treatment group vs. Placebo group
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Inactive Resonator Device
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)
Time Frame
end of treatment at 12 weeks
Secondary Outcome Measure Information:
Title
Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale
Time Frame
end of treatment at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack A Klapper, MD
Organizational Affiliation
Mile High Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Trevino, MD
Organizational Affiliation
Innovative Research of West Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Innovative Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States

12. IPD Sharing Statement

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Study of Magnetic Fields to Treat Alzheimer's Disease

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