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Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease

Primary Purpose

Alzheimer Disease

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Magnesium sulfate

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

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

Inclusion Criteria:

Outpatients with a diagnosis of Alzheimer's disease.
Exhibiting an onset and progression of cognitive dysfunction during at least 3 months prior to the screening period.
Subject or representative is willing to sign the consent for prior to enrollment into the study and to participate in all aspects of the study. Prospective subject must give verbal assent if unable to sign written consent.

Exclusion Criteria:

Patients with neurodegenerative diseases other than Alzheimer's disease.
Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc.
Patients with clinically significant cardiovascular disease.
Patients with history of clinically-evident stroke.
Patients with history of cancer in the last 5 years.
Patients with clinically-significant systemic illness that may affect safety or completion of the study.
Currently taking any medications that are known to interact with magnesium.
Currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnesium sulfate

Arm Description

All participants will apply magnesium sulfate transdermally a total of 250mg equivalent to 2 mEq every four hours per day for 90 days.

Outcomes

Primary Outcome Measures

Change in amyloid deposit

Amyloid deposit measure will mean change from baseline to 12 weeks in Florbetapir cortical-to-cerebellar ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus).Brain imaging focusing on the following anatomical regions: medial temporal region (including hippocampus andentorhinal cortex), prefrontal cortex, parietotemporal cortex, posterior cingulate cortex.

Secondary Outcome Measures

Cognitive Function

Composite scores for the four following cognitive areas include: 1) memory composite score 2) attention composite score 3) learning composite score 4) executive function composite score

Full Information

NCT ID

NCT03038334

First Posted

January 26, 2017

Last Updated

January 27, 2017

Sponsor

Metabolic Therapy Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03038334

Brief Title

Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease

Official Title

Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 20, 2017 (Anticipated)

Primary Completion Date

August 20, 2019 (Anticipated)

Study Completion Date

October 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Metabolic Therapy Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to examine the possible effect of supplementing Magnesium sulfate on patients with Alzheimer Disease (AD) in controlling or reducing the amount of amyloid present in the brain, and increasing cognitive ability in individuals that have amyloid deposits.

Detailed Description

Recent findings suggest magnesium may be effective in ameliorating symptoms in an Alzheimer's disease-like pathological progression by reducing Aβ-plaque, thus preventing synapse loss and memory decline in transgenic mice. Common forms include magnesium sulfate. As a nutritional adjunct in hyperalimentation, the precise mechanism of action for magnesium is uncertain. Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of magnesium. While there are large stores of magnesium present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral magnesium therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease. To provide a comprehensive clinical evaluation of the effects of Magnesium sulfate in AD patients, this study is designed to assess the impact of magnesium sulfate on amyloid plaque to generate valuable data on clinical utility for the use of diagnostic algorithms and foundation for the development of possible treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magnesium sulfate

Arm Type

Experimental

Arm Description

All participants will apply magnesium sulfate transdermally a total of 250mg equivalent to 2 mEq every four hours per day for 90 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Magnesium sulfate

Intervention Description

Transdermal application of Magnesium sulfate 250mg every four hours per day for 90 days.

Primary Outcome Measure Information:

Title

Change in amyloid deposit

Description

Time Frame

Baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Cognitive Function

Description

Composite scores for the four following cognitive areas include: 1) memory composite score 2) attention composite score 3) learning composite score 4) executive function composite score

Time Frame

Baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients with a diagnosis of Alzheimer's disease. Exhibiting an onset and progression of cognitive dysfunction during at least 3 months prior to the screening period. Subject or representative is willing to sign the consent for prior to enrollment into the study and to participate in all aspects of the study. Prospective subject must give verbal assent if unable to sign written consent. Exclusion Criteria: Patients with neurodegenerative diseases other than Alzheimer's disease. Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc. Patients with clinically significant cardiovascular disease. Patients with history of clinically-evident stroke. Patients with history of cancer in the last 5 years. Patients with clinically-significant systemic illness that may affect safety or completion of the study. Currently taking any medications that are known to interact with magnesium. Currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dewey C Brown II, PhD

Phone

2145174004

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreana Haley, PhD

Organizational Affiliation

University of Texas - Austin

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease

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