Memory XL Effects on Mild Cognitive Impairment Patients
| Status: | Archived |
|---|---|
| Conditions: | Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2009 |
| End Date: | January 2015 |
Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients
A vitamine nutriceutical, Memory XL, has been shown to provide maintenance of cognitive
status in mild, moderate, and severe Alzheimer's disease patients (2 publications by T.
Shea). Because this nutriceutical is now patented by the Univ. of Mass., other trials at
that institution may be considered a conflict of interest. Therefore, a study of its effects
on Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated
with Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or
improve the cognitive and behavioral status of patients diagnosed with MCI during the year
of participation in the study; normally, 25% of MCI patients convert to mild dementia each
year.
This IRB-approved study is a randomized double blind study of patients diagnosed in the
Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC OKC, and at the OUHSC
Center for Memory Loss and Dementia (CMLD). Dr. Shea will provide the pills and placebos
from the same batches he used in former studies of dementia patients (produced by Nutricap
Labs, Farmingdale, NY). Pills will be dispensed by the OU Pharmacist Care Center, using a
random numbering system, by two co-investigators who are the Pharm. D.'s at the campus
pharmacy. The PI will complete four cognitive testing sessions, lasting 1 to 1.5 hours, for
each subject during the 12 months of participation in the study. Subject's spouse or family
member will complete questionnaires about the subject's health and behavior, and will note
the times each day when the subject ingests the study pill/placebo. All subjects will be
patients in the two memory loss clinics (CANDO/CMLD) and will be monitored by their
neurologists (3), who are all co-investigators in this study.
We found this trial at
2
sites
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