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

NCT02210286 | Completed Results

• 1 other identifier: 29329
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Alzheimer's Disease

Keywords

dementia; magnesium; learning; memory; Alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Change From Baseline in CMRgl

  Baseline to Day 67

• RBC Magnesium Chemistry

  Baseline and 6 months

Study Arms (1)

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.

Dietary Supplement: Magtein

Interventions

Magtein DIETARY_SUPPLEMENT

Also known as: magnesium l-threonate

Magtein

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• 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).

Sponsors & Collaborators

• Stanford University: lead
• Magceutics, Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

threonic acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Alison Myoraku
• Organization: Stanford University

myoraku@stanford.edu

6507244559

Study Officials

• Natalie L Rasgon, MD, Ph.D

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Center for Neuroscience in Women's Health

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 6, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)