Clinical trial NCT03038334: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Metabolic Therapy Inc.
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in amyloid deposit
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Cognitive Function
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas - Austin
name: Andreana Haley, PhD
role: PRINCIPAL_INVESTIGATOR
References: