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| Name | Class |
|---|---|
| Magceutics, Inc. | INDUSTRY |
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The purpose of this study is to examine the effects of supplementing Magnesium L-Threonate in people with mild to moderate dementia. The investigators' goal is to understand whether Magnesium L-Threonate will be associated with improvement in memory and brain function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magtein | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magtein | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Function | 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) | Baseline and 6 months |
| Change From Baseline in Cognitive Function (DKEFS Color-Word Test) | 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 | Baseline and 6 months |
| Change From Baseline in Cognitive Function (DKEFS - Trail 4) | This is a graphomotor test comprised of 5 conditions. Condition 4 (Number Letter Switching) is a measure of cognitive flexibility | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CMRgl | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie L Rasgon, MD, Ph.D | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magtein | 17 subjects were then enrolled into the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Magtein Subjects | Inclusion criteria included adults of either gender > 60 years of age (women had to be post-menopausal), a diagnosis of probable AD from their physician, a Mini-Mental State Examination (MMSE) between 14 and 24, adequate visual and auditory acuity to allow for neuropsychological testing, at least 12 years of education (or a GED to allow consistency of the sample), and willingness to or having a representative willing to sign the informed consent prior to enrollment into the study (for those subjects unable to sign or understand informed consent, assent to participate in the study was required), and agreeing to discontinue vitamins, minerals, or dietary/herbal supplements for at least 7 days prior to study entry and until after study completion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Cognitive Function | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magtein Adverse Events | See Table below for details on adverse event. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Problem | Gastrointestinal disorders | Systematic Assessment | 1 subject developed mild gastrointestinal discomfort after taking MMFS-201-101 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Myoraku | Stanford University | 6507244559 | myoraku@stanford.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| C011369 | threonic acid |
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| Baseline to Day 67 |
| RBC Magnesium Chemistry | Magnesium (mg/dl) in red blood cells | Baseline and 6 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Two participants discontinued the intervention before analysis | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change From Baseline in Cognitive Function (DKEFS Color-Word Test) | 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 | Posted | Mean | Standard Deviation | total number of errors | Baseline and 6 months |
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|
|
| Primary | Change From Baseline in Cognitive Function (DKEFS - Trail 4) | This is a graphomotor test comprised of 5 conditions. Condition 4 (Number Letter Switching) is a measure of cognitive flexibility | Posted | Mean | Standard Deviation | time in seconds | Baseline to 6 months |
|
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| Secondary | Change From Baseline in CMRgl | 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. | Posted | Mean | Standard Deviation | mmol·min-1·100 g-1 | Baseline to Day 67 |
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| Secondary | RBC Magnesium Chemistry | Magnesium (mg/dl) in red blood cells | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
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| 17 |
| 1 |
| 17 |
| 0 |
| 17 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |