Alzheimer's Clinical Trial Protocol - Pico-Tesla Magnetic Therapies, LLC

		Alzheimer's Clinical Study Information The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease. Overview Device User Interface Safety and Risks FDA Clearance Overview The Resonator™ Device Compared to Other Magnetic Devices and Parkinson’s Disease Therapies The Device Versus MRI (Magnetic Resonance Imaging) The Device Versus TMS and rTMS The Device Versus Other Parkinson’s Disease Therapies Overview Jacobson Resonance™

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Study Contact Information
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Monitor
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Study Consultant
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Treatment Site
Institutional Review Board (IRB)

Device Information
Device Description
Signal Generator
Helmholtz Coils
Regulatory Status
Determination of Device Safety
IRB Determination of Device Safety

Study Information
Study Indication & Rationale
Study Treatment Modality: EM Stimulation
Theory of Mechanism of Operation (Part 1)
Theory of Mechanism of Operation (Part 2)
Theory of Mechanism of Operation (Part 3)

Study Design
Purpose
Study Objectives
Procedure Groups
Single-Blind Design
Randomization Procedure
Subjects
Inclusion Criteria
Exclusion Criteria
Measurements & Procedures

Study Procedures
Screening Visit
Treatment Administration Phase (Part 1)
Treatment Administration Phase (Part 2)
Titration Description
Group A Sample Approach
Group 2 Sample Approach
Post-Treatment Phase (Week 12)
Post-Treatment Phase (Months 1 & 2)
Safety Evaluation
Privacy and Confidentiality
Monitoring of the Clinical Study
Statistical Analysis Plan
Informed Consent
Case Report Forms
Research Personnel Training & Certification

Monitoring of the Clinical Study

The Monitor will assure that the investigator is executing the protocol exactly as outlined and intended. This includes insuring that a signed informed consent form has been attained from each subject prior to commencing the protocol, that the research procedure protocol is administered as specified, and that all study evaluations and measurements are taken using the specified methods and correctly and fully recorded on the appropriate clinical case report forms.

Statistical Analysis Plan

As this first phase study is observational, designed to evaluate the changes in pre- and post-procedure cognitive and executive function to determine a primary efficacy outcome measure for a subsequent placebo-controlled clinical study, there is no prospective statistical analysis plan.

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical^®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.