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

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ClinicalTrials.gov Identifier: NCT03038334
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Metabolic Therapy Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: Magnesium sulfate Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease
Estimated Study Start Date : February 20, 2017
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : October 20, 2019


Arm Intervention/treatment
Experimental: Magnesium sulfate
All participants will apply magnesium sulfate transdermally a total of 250mg equivalent to 2 mEq every four hours per day for 90 days.
Dietary Supplement: Magnesium sulfate
Transdermal application of Magnesium sulfate 250mg every four hours per day for 90 days.




Primary Outcome Measures :
  1. Change in amyloid deposit [ Time Frame: Baseline to 12 weeks ]
    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 :
  1. Cognitive Function [ Time Frame: Baseline to 12 weeks ]
    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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038334


Contacts
Contact: Dewey C Brown II, PhD 2145174004

Sponsors and Collaborators
Metabolic Therapy Inc.
Investigators
Principal Investigator: Andreana Haley, PhD University of Texas Austin

Responsible Party: Metabolic Therapy Inc.
ClinicalTrials.gov Identifier: NCT03038334     History of Changes
Other Study ID Numbers: PR02TCR011-17
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents