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

NCT03038334 | Unknown DMC

• 1 other identifier: PR02TCR011-17
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 weeks

Secondary Outcomes (1)

• Cognitive Function

  Baseline to 12 weeks

Study Arms (1)

Magnesium sulfate

EXPERIMENTAL

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

Interventions

Magnesium sulfate DIETARY_SUPPLEMENT

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

Magnesium sulfate

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabolic Therapy Inc.: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Andreana Haley, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dewey C Brown II, PhD

CONTACT

2145174004

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: February 20, 2017
• Primary Completion: August 20, 2019
• Study Completion: October 20, 2019
• Last Updated: January 31, 2017

Record last verified: 2017-01