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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Dietary Supplement: Magnesium sulfate||Not Applicable|
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)|
|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|
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.
- 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.
- 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
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
|Contact: Dewey C Brown II, PhD||2145174004|
|Principal Investigator:||Andreana Haley, PhD||University of Texas Austin|