A brief communication, published last month in the Journal of Prevention of Alzheimer’s Disease (JPAD), has used a new statistical analysis approach to show that 24 months of treatment with a multinutrient supplement may be linked to a 9-10 month “time saving” in terms of cognitive decline.
LipiDiDiet was a double-blind, multi-center randomised clinical trial designed to assess the safety and efficacy of a multinutrient supplement, Fortasyn Connect, compared to a control product, for people with prodromal Alzheimer’s disease (AD) or mild cognitive impairment. Fortasyn Connect, also known as Souvenaid, is a commercially-available multinutrient supplement that contains a number of vitamins and minerals. A 24-month analysis of LipiDiDiet data showed improvements on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale, but no improvement on the Neuropsychological test battery (NTB) scale. The study also evaluated changes in brain structure, using MRI scans.
Assessment of meaningfulness in clinical trials for Alzheimer’s disease is challenging, particularly in early disease. Converting clinical outcomes to disease progression time can help people to understand the value of an intervention on a scale that is meaningful to many people with Alzheimer’s disease: time. In the newly-published study, which was led by statisticians Susanne Hendrix and Samuel Dickson, a statistical analysis technique known as a “Time Component Test” (or TCT) was applied to the results of the LipiDiDiet trial. This approach can be applied to multiple outcome measures, combining the results across measures to compute the “time saved” by an intervention. Dr. Hendrix and Dr. Dickson applied the TCT technique to results from the CDR-SB and NDB scales, and the MRI measurements of hippocampal volume, for participants receiving Fortasyn Connect for 24 months. When the three domains were combined, an average time saving of 9 months with Fortasyn Connect was computed, when compared to the scores for individuals in the placebo arm of the trial.