Status:
COMPLETED
Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Magceutics, Inc.
Conditions:
Dementia
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
NA
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-Threon...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02210286
Start Date
July 1 2014
End Date
July 1 2016
Last Update
February 2 2021
Active Locations (1)
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1
Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences
Stanford, California, United States, 94305