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

Not Recruiting

Trial ID: NCT02210286

Purpose

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.

Official Title

The Use of Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Mild to Moderate Dementia

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - 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.

Intervention(s):

dietary supplement: Magtein

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Danielle R Balzafiore, MA
650-736-2182