MemoryXL Effects on Mild Cognitive Impairment Patients

Last updated: January 25, 2012
Sponsor: University of Oklahoma
Overall Status: Terminated

Phase

2

Condition

Dementia

Mild Cognitive Impairment

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT00903695
14594
  • Ages 55-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • MCI patients diagnosed at the VAMC Center for Alzheimers and NeurodegenerativeDisorder (CANDO).

  • Clinical Dementia Rating (CDR) score of 0.5.

  • fluent in English.

  • able to ambulate to the outpatient clinic and research laboratory

  • have sight and hearing levels sufficient to complete neuropsychological testing.

  • free from bipolar disorder and terminal illnesses such as cancer.

  • must live with a spouse or adult relative who will record nutriceutical ingestiondaily.

  • subjects will be consecutively diagnosed patients from all ethnic groups.

Exclusion

Exclusion Criteria:

  • patients from protected categories such as prisoners and pregnant women.

  • any MCI subject who develops a life-threatening disease such as terminal cancer,stroke, brain trauma, debilitating heart attack, etc.

  • indication of inability to make decisions regarding study participation.

Study Design

Total Participants: 10
Study Start date:
June 01, 2009
Estimated Completion Date:
May 31, 2011

Study Description

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).

Connect with a study center

  • Univ. of Okla. Health Sciences Center & VAMC OKC

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

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