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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Test Sites
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

Safety Evaluation

Adverse Events/Reactions
At each procedure administration visit, assessment time point, and at any other applicable time throughout the study, any potential adverse events and/or reactions reported by a subject or observed by the research staff at either the testing or treatment sites will be recorded on the case report form and subsequently evaluated by the Principal Investigator for its relation to the study research procedure and whether or not any corrective action need be taken. It is unlikely and not expected, that any adverse incident will result from implementation of this pilot study protocol. However, any and all adverse events that may occur will be recorded on the case report forms, and reported to the governing IRB, as applicable.

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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.