Alzheimer DiseaseNCT03038334
Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease
A study testing Magnesium sulfate in people with Alzheimer Disease, run by Metabolic Therapy Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2017to 20 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Dewey C Brown II, PhD contact
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Magnesium sulfate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDietary supplement
Transdermal application of Magnesium sulfate 250mg every four hours per day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Cognitive Function
Composite scores for the four following cognitive areas include: 1) memory composite score 2) attention composite score 3) learning composite score 4) executive function composite score
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start20 Feb 2017 (estimated)
- Primary completion20 Aug 2019 (estimated)
- Study completion20 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabolic Therapy Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreana Haley, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038334
- Sponsor's protocol ID
- PR02TCR011-17
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease
- ClinicalTrials.gov ID
- NCT03038334
- Acronym / sponsor ID
- PR02TCR011-17
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Metabolic Therapy Inc.University, hospital or other
- Study start
- 20 Feb 2017 (estimated)
- Primary completion
- 20 Aug 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Experimental | Dietary Supplement: Magnesium sulfateAll participants will apply magnesium sulfate transdermally a total of 250mg equivalent to 2 mEq every four hours per day for 90 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Magnesium sulfateTransdermal application of Magnesium sulfate 250mg every four hours per day for 90 days. | Dietary supplement | Magnesium sulfate |
Primary outcome
Change in amyloid deposit
Time frame: Baseline to 12 weeks
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.
1 secondary outcome
Cognitive Function
Time frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Dewey C Brown II, PhD contact
Andreana Haley, PhD principal investigator
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate in people with Alzheimer Disease, run by Metabolic Therapy Inc..
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dewey C Brown II, PhD (2145174004), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amyloid deposit (time frame: Baseline to 12 weeks). 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 31 Jan 2017.