Clinical Trial: MemoryXL Effects on Mild Cognitive Impairment Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients

Brief Summary: A vitamin 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, 10-25% of MCI patients convert to mild Alzheimer's dementia each year.

Detailed Summary: This IRB-approved study is a randomized double blind study of patients diagnosed with Mild Cognitive Impairment (MCI) in the Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC in Oklahoma City. Dr. Shea provided the pills (nutriceutical and placebos) from the same batches he used in former studies of Alzheimer's disease patients (produced by Nutricap Labs, Farmingdale, NY). Pills were dispensed by the OKC VAMC research pharmacist, using a random numbering system. The PI completed five 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 completed 4 questionnaires about the subject's behavioral changes, and kept daily records of the times each day when the subject ingested the study pill assigned by the pharmacist. All subjects are patients in the VAMC memory loss clinic (CANDO) who are monitored by their neurologists (2 co-investigators in this study).
Sponsor: University of Oklahoma

Current Primary Outcome:

  • Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group [ Time Frame: Baseline and 12 months ]
    Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.
  • Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group [ Time Frame: baseline before intervention to 12 months of intervention ]
    CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.
  • Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]
    Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-m

    Original Primary Outcome: All cognitive and behavioral test scores will remain constant or show improvement in subjects taking Memory XL. No subjects will show side effects or adverse affects that stop them from participation (in placebo or Memory XL arms). [ Time Frame: 12 months ]

    Current Secondary Outcome: Number of Subjects Who Converted to Early Alzheimer's (Dementia). [ Time Frame: 12 months ]

    Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.


    Original Secondary Outcome: No subjects will convert of early Alzheimer's disease while taking Memory XL, but at least 25% of subjects taking the placebo will convert to early stage AD. [ Time Frame: 12 months ]

    Information By: University of Oklahoma

    Dates:
    Date Received: May 14, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: January 25, 2012
    Last Verified: January 2012