DementiaNCT02210286
Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia
A study testing Magtein in people with Dementia and Alzheimer's Disease, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- Magtein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People of either gender > 60 years of age.
- Subject scores between 16 and 26 on the MMSE
- 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.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Greater than 12 years of educational achievement, or a General Education Development certificate to allow adequate neuropsychological testing, and consistency of sample.
- Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control.
- Subject agrees to stop taking any vitamins, minerals, or dietary/herbal supplements he/she is currently taking at least 7 days prior to randomization and agrees to not take any vitamins, minerals or dietary/herbal supplements other than the study product until after study completion.
Who cannot join
- Active heart disease
- Uncontrolled high blood pressure (≥ 140/90 mmHg)
- Renal or hepatic impairment/disease
- Type I diabetes
- Unstable thyroid disease
- Psychiatric disorder (hospitalized in the past year)
Show all 23Show fewer
- History of drug or alcohol abuse.
- Immune disorder (such as HIV/AIDS)
- TIAs, carotid bruits, or verified lacunes
- Significant pulmonary disease
- Contraindication for a PET scan including those who have had a stroke or heart attack in the past 6 months, and those unable or unwilling to lie down for 1 hour.
- Any medical condition deemed exclusionary by the Principal Investigator (PI)
- History of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
- 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.
- On an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Currently taking any medication deemed exclusionary by PI.
- Allergy or sensitivity to any ingredient in the test product.
- Evidence of hepatic or renal dysfunction
- History of drug or alcohol abuse in the past 12 months.
- Pregnant , lactating, or planning to become pregnant during the study period.
- Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Subject is participating or has participated in another research study within 30 days prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences
Stanford, California, 94305
About this study
Official title: The Use of Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Mild to Moderate Dementia
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.
Read the detailed description
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.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- Magtein
- Keywords
- dementia, magnesium, learning, memory, Alzheimer's disease
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagteinDietary supplement
Also called magnesium l-threonate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Magtein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 6 months
Change From Baseline in Cognitive Function (DKEFS Color-Word Test)
- Delis-Kaplan Executive Function System Color-Word Test (DKEFS, assesses executive functioning): no minimum or maximum set, higher is worse, total number of errors
Measured: 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
Measured: Baseline to 6 months
Secondary outcomes (2)
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.
Measured: Baseline to Day 67
RBC Magnesium Chemistry
Magnesium (mg/dl) in red blood cells
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Magceutics, Inc.
- Responsible party
- Principal investigator, Natalie Rasgon, Stanford University
- Investigators
- Natalie L Rasgon, MD, Ph.D, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210286
- Sponsor's protocol ID
- 29329
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2014
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Mild to Moderate Dementia
- ClinicalTrials.gov ID
- NCT02210286
- Acronym / sponsor ID
- 29329
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- dementia, magnesium, learning, memory, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Magceutics, Inc.
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magtein | Experimental | Dietary Supplement: MagteinAll 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People of either gender > 60 years of age.
- Subject scores between 16 and 26 on the MMSE
- 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.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Greater than 12 years of educational achievement, or a General Education Development certificate to allow adequate neuropsychological testing, and consistency of sample.
Key exclusion criteria (23 listed)
- Active heart disease
- Uncontrolled high blood pressure (≥ 140/90 mmHg)
- Renal or hepatic impairment/disease
- Type I diabetes
- Unstable thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagteinAlso: magnesium l-threonate | Dietary supplement | Magtein |
Primary outcome
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
2 secondary outcomes
Change From Baseline in CMRgl
Time frame: Baseline to Day 67
RBC Magnesium Chemistry
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie L Rasgon, MD, Ph.D principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magtein in people with Dementia and Alzheimer's Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Cognitive Function (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.