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Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210286
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
Magceutics, Inc.
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dementia
Alzheimer's Disease
Intervention Dietary Supplement: Magtein
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Magtein
Hide Arm/Group Description 17 subjects were then enrolled into the study
Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Arm/Group Title Magtein Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
17
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
77.0  (5.86)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
7
  46.7%
Male
8
  53.3%
[1]
Measure Analysis Population Description: Two participants discontinued the intervention before analysis
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Change From Baseline in Cognitive Function
Hide Description

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)
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magtein Cognitive Data
Hide Arm/Group Description:
Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
ADAS-COG -0.58  (7.58)
MMSE -1.73  (2.49)
RBANS -0.36  (8.83)
WAIS -0.07  (1.86)
2.Primary Outcome
Title Change From Baseline in Cognitive Function (DKEFS Color-Word Test)
Hide Description 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
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change From Baseline in Cognitive Function (DKEFS)
Hide Arm/Group Description:
Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: total number of errors
0.8  (4.23)
3.Primary Outcome
Title Change From Baseline in Cognitive Function (DKEFS - Trail 4)
Hide Description This is a graphomotor test comprised of 5 conditions. Condition 4 (Number Letter Switching) is a measure of cognitive flexibility
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change From Baseline in Cognitive Function (DKEFS - Trail 4)
Hide Arm/Group Description:
Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: time in seconds
23.5  (88.5)
4.Secondary Outcome
Title Change From Baseline in CMRgl
Hide Description

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.
Time Frame Baseline to Day 67
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change in CMRgl From Baseline
Hide Arm/Group Description:
We examined CMRgl changes using our summary index statistical region of interest (sROI) which is free of the multiple comparison concern.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mmol·min-1·100 g-1
0.0093  (0.031)
5.Secondary Outcome
Title RBC Magnesium Chemistry
Hide Description Magnesium (mg/dl) in red blood cells
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change in RBC Magnesium
Hide Arm/Group Description:
Change in the amount of magnesium in red blood cells (mg/dl) from baseline
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.007  (1.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Magtein Adverse Events
Hide Arm/Group Description See Table below for details on adverse event.
All-Cause Mortality
Magtein Adverse Events
Affected / at Risk (%)
Total   0/17 (0.00%)    
Hide Serious Adverse Events
Magtein Adverse Events
Affected / at Risk (%) # Events
Total   1/17 (5.88%)    
Gastrointestinal disorders   
GI Problem † [1]  1/17 (5.88%)  1
†
Indicates events were collected by systematic assessment
[1]
1 subject developed mild gastrointestinal discomfort after taking MMFS-201-101
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Magtein Adverse Events
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alison Myoraku
Organization: Stanford University
Phone: 6507244559
EMail: myoraku@stanford.edu
Layout table for additonal information
Responsible Party: Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier: NCT02210286    
Other Study ID Numbers: 29329
First Submitted: August 1, 2014
First Posted: August 6, 2014
Results First Submitted: July 27, 2020
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021