Poster - Monitoring cognitively-impaired subjects in an interactive Internet-based clinical trial of a multi-factorial treatment based on a molecular model of chronic disease

Type: Abstract presentation
Presented by: Meg Mangin RN
Conference: Days of Molecular Medicine 2008
Location: Karolinska Institue, Sweden
Date: April 17 -19, 2008
Related content: poster; Notes from the Conference by Amy Proal
Notes: Meg Mangin's presentation begins at 16:50.

Based on this author’s experience on an NIH monitoring board, we devised and conducted a phase II clinical study of a VDR-agonist, antibacterial therapy which demonstrated proof of concept of a novel biological description of the autoimmune disease process¹⁾. We collected evidence that restoring innate immune system competence will reverse the disease progression²⁾. This multi-factorial therapy activates the Vitamin D Nuclear-Receptor, enabling the innate immune system to attack the intracellular microbiota which dysregulates Vitamin D metabolism. Additionally, it reduces elevated 1,25-dihydroxyvitamin-D and reduces co-morbid cognitive impairment³⁾. Nurses who monitor the subject’s progress are well-grounded in molecular science to help them accurately assess the effects of the recovery process. Instruction of subjects and their participating physicians occurs online. All communication is done in writing using a standard report form to facilitate accurate assessment and collect objective data. Ongoing, regular reports and rapid feedback by Nurses, ensures early detection of unexpected treatment effects. We describe the observational skills needed, the assessment techniques used and the limits/advantages of monitoring subjects using this format. As a result of the therapy subjects experienced diminishing relapse and remission of inflammatory symptoms⁴⁾. Over 3-5 years this resulted in recovery from the disease process.