In the proposed effort, GW Medical Technologies will asses the benefits, risks, and effectiveness of a peripheral blood lymphocyte (PBL) simulation index diagnostic test for Alzheimer's disease (AD). The company's test detects AD by evaluating a patient's stimulation index against a predetermined cutoff, where the stimulation index is defined as the ratio CD69 presentation on mitogenicly stimulated peripheral blood lymphocytes to the CD69 presentation of un-stimulated lymphocytes. In preliminary studies the company found a statistically significant difference (p<0.05) in the mean stimulation index of AD patients and cognitively intact controls and was able to identify samples from AD """"""""probable"""""""" patients with high sensitivity and selectivity (83% and 96% respectively). However, these early results are suspect due to the limitations of the original test methodology and protocol. Early testing relied on manual processes for data collection, transfer and analysis, which could introduce significant errors. Early testing also used a small sample size (n=72) and did not include samples from patients with other forms of dementia. In the proposed effort, the company addresses all three of these limitations by developing automated routines for data collection, handling and analysis and by conducting a randomized, blind clinical study (n=300) that includes control samples from both cognitively intact individuals and patients with other forms of dementia. Should this study prove successful, a this test could provide a preclinical diagnosis of AD, improve patents' quality of life, and reduce the cost of care.
| Stieler, Jens; Grimes, Randy; Weber, Don et al. (2012) Multivariate analysis of differential lymphocyte cell cycle activity in Alzheimer's disease. Neurobiol Aging 33:234-41 |
