Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia
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|ClinicalTrials.gov Identifier: NCT02210286|
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer's Disease||Dietary Supplement: Magtein||Not Applicable|
Emerging research on the effects of a novel magnesium compound of L-Threonic Acid Magnesium Salt (L-TAMS) containing Vitamins C and D on cognitive performance suggests that supplementation may benefit individuals with Alzheimer's disease (AD). This proof of concept will assess whether supplementation with Magtein (MGT), a constant release formula of Magnesium L-threonate, Vitamin C, and Vitamin D, is associated with changes in regional cerebral metabolism in elderly people with mild to moderate dementia.
This is an open-label, two-month trial consisting of 15-20 participants aged 60 and older with mild to moderate dementia. Subjects will receive 1,800 mg/day of MgT-1219 for a total of 60 days. They will be given neurocognitive testing, blood chemistries, and FDG-PET imaging at baseline, 60 days and more testing at 180 days to assess the acute effect of MgT-1219 on hippocampal and PFC-mediated executive function, attention, reasoning, and memory. Blood draws will be conducted prior to treatment initiation to assess kidney and liver function, complete blood count, fasting plasma insulin, and red blood cell magnesium.
Our outcome measures include a combination of neuropsychological testing and neuroimaging. These will be employed to measure changes in the degree of cognitive impairment within subjects over time, as well as between subjects in the intervention and control groups. FDG-PET imaging will be used to assess the degree of synaptic activity and density within subjects at different time points in the study. These measures will be supplemented by measures of, sleep quality, daytime sleepiness, depression, and activities of daily living.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Mild to Moderate Dementia|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||July 2016|
All participants will orally take a total of 1800 mg/day for 60 days. Oral administration includes two pills 2 hours before bed time and one pill in the morning, each pill containing 600 mg of MgT-1219.
Dietary Supplement: Magtein
Other Name: magnesium l-threonate
- Change From Baseline in Cognitive Function [ Time Frame: Baseline and 6 months ]
Neurocognitive assessment - Domain-specific composite scores for the four following cognitive areas include:
1a) Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-COG) (min: 0, max: 70, higher = better, units on a scale)
1b) Mini Mental Status Examination (MMSE) (min: 0, max : 30, higher = better, units on a scale)
1c) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (min: 40, max: 160, higher = better, units on a scale)
1d) Wechsler Adult Intelligence Scale - Fourth edition (WAIS-IV) (min: 85 , max: 115, higher = better, units on a scale)
- Change From Baseline in Cognitive Function (DKEFS Color-Word Test) [ Time Frame: Baseline and 6 months ]1) Delis-Kaplan Executive Function System Color-Word Test (DKEFS, assesses executive functioning): no minimum or maximum set, higher is worse, total number of errors
- Change From Baseline in Cognitive Function (DKEFS - Trail 4) [ Time Frame: Baseline to 6 months ]This is a graphomotor test comprised of 5 conditions. Condition 4 (Number Letter Switching) is a measure of cognitive flexibility
- Change From Baseline in CMRgl [ Time Frame: Baseline to Day 67 ]
Brain imaging focusing on the following anatomical regions: medial temporal region (including hippocampus and entorhinal cortex), prefrontal cortex, parietotemporal cortex, posterior cingulate cortex. Increases in the summary index sROI have been shown to track AD-related CMRgl declines.
We will be focusing on changes in the cerebral metabolic rate for glucose (CMRgl) from baseline to day 67.
- RBC Magnesium Chemistry [ Time Frame: Baseline and 6 months ]Magnesium (mg/dl) in red blood cells
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): NCT02210286
|United States, California|
|Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences|
|Stanford, California, United States, 94305|
|Principal Investigator:||Natalie L Rasgon, MD, Ph.D||Stanford University|