Trial Outcomes & Findings for Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia (NCT NCT02210286)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Magtein 17 subjects were then enrolled into the study
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants discontinued the intervention before analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magtein Subjects n=17 Participants 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.
Age, Categorical <=18 years	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=17 Participants
Age, Categorical >=65 years	17 Participants n=17 Participants
Age, Continuous	77.0 years STANDARD_DEVIATION 5.86 • n=17 Participants
Sex: Female, Male Female	7 Participants n=15 Participants • Two participants discontinued the intervention before analysis
Sex: Female, Male Male	8 Participants n=15 Participants • Two participants discontinued the intervention before analysis
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Magtein Cognitive Data n=17 Participants 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.
Change From Baseline in Cognitive Function RBANS	-0.36 units on a scale Standard Deviation 8.83
Change From Baseline in Cognitive Function WAIS	-0.07 units on a scale Standard Deviation 1.86
Change From Baseline in Cognitive Function ADAS-COG	-0.58 units on a scale Standard Deviation 7.58
Change From Baseline in Cognitive Function MMSE	-1.73 units on a scale Standard Deviation 2.49

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Magtein Cognitive Data n=17 Participants 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.
Change From Baseline in Cognitive Function (DKEFS Color-Word Test)	0.8 total number of errors Standard Deviation 4.23

PRIMARY outcome

Timeframe: Baseline to 6 months

This is a graphomotor test comprised of 5 conditions. Condition 4 (Number Letter Switching) is a measure of cognitive flexibility

Outcome measures

Outcome measures
Measure	Magtein Cognitive Data n=17 Participants 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.
Change From Baseline in Cognitive Function (DKEFS - Trail 4)	23.5 time in seconds Standard Deviation 88.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magtein Cognitive Data n=17 Participants 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.
Change From Baseline in CMRgl	0.0093 mmol·min-1·100 g-1 Standard Deviation 0.031

SECONDARY outcome

Timeframe: Baseline and 6 months

Magnesium (mg/dl) in red blood cells

Outcome measures

Outcome measures
Measure	Magtein Cognitive Data n=17 Participants 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.
RBC Magnesium Chemistry	-0.007 mg/dl Standard Deviation 1.16

Adverse Events

Magtein Adverse Events

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Magtein Adverse Events n=17 participants at risk See Table below for details on adverse event.
Gastrointestinal disorders GI Problem	5.9% 1/17 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Alison Myoraku

Stanford University

Phone: 6507244559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place