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Oral presentation on post hoc analysis of the LipiDiDiet study at CTAD

At CTAD worldwide leaders in the field of Alzheimer’s Disease (AD) come together to discuss new results, candidate therapeutics, and methodological issues important to the development of the next generation solutions in AD. This year CTAD is held from 24 – 27 October in Barcelona.

Suzanne Hendrix (Pentara Corporation, US), expert in Alzheimer’s Disease statistics, will present  on behalf of the LipiDiDiet consortium – in which Danone Nutricia Research is partner. Hendrix’ oral presentation entitled “ADCOMS: a post-hoc analysis using data from the LipiDiDiet trial in prodromal Alzheimer’s disease” will be held on Saturday October 27th.

The post-hoc analysis of the LipiDiDiet study  used a composite clinical outcome measure: Alzheimer’s Disease Composite Score or ADCOMS . ADCOMS was recently developed to measure changes and treatment effects over time on cognition and global function in early AD subjects. This outcome measure was developed after the initiation of the LipiDiDiet trial and was therefore not available to include in the trial. Recent results using ADCOMS were interpreted as supporting its applicability in early AD. Further validating its general applicability would benefit from generating more data both by using it in new studies and by post-hoc analyses.

Objective

The objective of this post-hoc analysis using data from the LipiDiDiet trial, was to explore the effects of a specific neuroprotective multinutrient intervention on cognition and global function, as captured by ADCOMS and its subdomains. Additionally, this analysis gives insights with regards to the utility of ADCOMS as a single clinical outcome measure in early AD trials.

Conclusions

In this post-hoc analysis of the LipiDiDiet study data, the active group showed significantly less clinical decline (36%) over 24 months as measured by the ADCOMS. This supports the earlier findings from secondary endpoints using CDR-SB (Clinical Dementia Rating – Sum of Boxes), that the specific multinutrient intervention has beneficial effects on cognition and global function in a prodromal AD population, but this time using ADCOMS, an emerging tool with higher sensitivity in detecting treatment effects on cognition in this population. These analyses further contribute to the validation of the ADCOMS in early AD and support its applicability and sensitivity across different intervention strategies in the earliest stages of AD.

About CTAD

Overall, the aim of the CTAD conference is to overcome the hurdles in clinical trials and speed up the development of effective treatments. During this conference, international clinical teams active in the field of Alzheimer’s disease will report on their efforts to develop more sensitive clinical assessment tools to identify those at risk of AD, to predict progression, and assess the efficacy of new treatments.