Last updated: January 29, 2021
Sponsor: Stanford University
Overall Status: Completed
Phase
N/A
Condition
Memory Loss
Dementia
Alzheimer's Disease
Treatment
N/AClinical Study ID
NCT02210286
29329
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 intothe study and to participate in all aspects of the study. Prospective subject mustgive 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 Developmentcertificate to allow adequate neuropsychological testing, and consistency of sample.
- Female subject is surgically sterile, post-menopausal or agrees to use an acceptablemethod of birth control.
- Subject agrees to stop taking any vitamins, minerals, or dietary/herbal supplementshe/she is currently taking at least 7 days prior to randomization and agrees to nottake any vitamins, minerals or dietary/herbal supplements other than the study productuntil after study completion.
Exclusion
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 attackin 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 cervicalcancer) 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 ofantibiotics. 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 daysprior to the screening visit.
Study Design
Total Participants: 17
Study Start date:
July 01, 2014
Estimated Completion Date:
July 31, 2016
Study Description
Connect with a study center
Stanford University School of Medicine, Department of Psychiatry & Behavioral Sciences
Stanford, California 94305
United StatesSite Not Available
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