MemoryXL Effects on Mild Cognitive Impairment Patients

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma

Criteria

Inclusion Criteria:

• MCI patients diagnosed at the VAMC Center for Alzheimers and Neurodegenerative Disorder (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 ingestion daily.

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

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.