drugset / Trial / NCT00903695

MemoryXL Effects on Mild Cognitive Impairment Patients

NCT00903695 ↗

Phase 2 Terminated 10 enrolled University of Oklahoma
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2009-06
Primary completion
2011-05
Completion
2011-05

Outcome

Missed primary endpoint

Stopped: “Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.”

registry analysis (superiority or other test); Nutriceutical (MemoryXL) Effects on Cognition & Behavior vs Placebo Effects on Cognition/Behavior; p = 0.8133; ANOVA NCT00903695 ↗

registry analysis (superiority or other test); Nutriceutical Arm vs Placebo Arm; p = 0.31; ANOVA NCT00903695 ↗

Publications

  • Background Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).

Drugs

EvaluationDrugModalityDoseRoute
Subject Memory XL Other / unclassified 2 unknown —