Inflammatory and immune profiling in children and adolescents with attention-deficit/ hyperactivity disorder (ADHD): a matched case–control study with longitudinal on/off psychostimulant assessment (ANIME)

Topic/Product:
CNS Disease Panel 120, Neurology
Disease Area:
ADHD
Sample Type:
Plasma

Abstract

Background

Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental condition with high societal impact. While psychostimulants like methylphenidate (MPH) are first-line treatments, 10–20% of patients show insufficient efficacy, and many experience side effects such as sleep and appetite disturbances. Emerging evidence suggests that neuroinflammation and oxidative stress contribute to ADHD pathophysiology. Animal studies indicate that MPH may induce pro-inflammatory processes, but this has yet to be characterized in humans.

Methods

The ANIME study (ADHD Nutritional, Inflammatory, and Metabolic Endophenotypes) employs a combined case-control and prospective cohort design. A case-control study will compare the immune, inflammatory, and nutritional profiles of 40 children/adolescents with ADHD against 40 age- (± 2 years) and sex-matched typically developing controls. The ADHD group will have a follow-up visit to assess the impact of psychostimulant treatment). The primary outcome is the comparison of the immune and inflammatory markers’ levels, particularly IL-6 levels, at baseline. Secondary outcomes include deep immunophenotyping via spectral flow cytometry (Cytek Aurora) and high-sensitivity multiplex proteomics (NULISA), alongside assessments of polyphenol bioavailability, diet quality (KIDMED), and clinical symptoms.

Discussion

ANIME will provide an in-depth characterization of the “inflammatory biotype” in ADHD, specifically examining how psychostimulants interact with pre-existing immune states. By integrating metabolic, nutritional, and clinical data, the study aims to identify biomarkers for treatment response and tolerability, ultimately informing personalized care and future trials of antioxidant-rich adjunct therapies like polyphenols.

Authors & Affiliations

Erica Fongaro¹², Quentin Leyrolle⁵, Charlotte Madore³, Sylvain Lehmann⁵, Marie-Christine Picot⁴, Sophie Laye⁵, and Diane Purper-Ouakil¹²

¹ Department of Child and Adolescent Psychological Medicine, Montpellier University Hospital, Montpellier, Hérault, France
² Developmental Psychiatry/ADHD and Emotional Disorders, INSERM U1018, CESP, Villejuif, France
³ University Bordeaux, INRAE, Bordeaux INP, NutriNeuro, UMR 1286, Bordeaux F-33000, France
⁴ Clinical Research and Epidemiology Unit, DIM (Medical Information Department), Montpellier University Hospital, Montpellier, France
⁵ LBPC-PPC, Université de Montpellier, INM INSERM, IRMB CHU de Montpellier, Montpellier, France

Steve Williams, MD, PhD

CSO

Dr. Willams serves as the company’s Chief Scientific Officer. He was previously Chief Medical Officer at Standard Biotools and at SomaLogic where he pioneered the discipline for discovery and validation of predictive, diagnostic and prognostic models using machine-learning applied to large-plex proteomics. 20 such tests were used for drug characterization, safety and efficacy when incorporated in clinical drug trials at Pharma/Biotech and 17 different multivariate tests were validated and translated into regulated healthcare uses. Prior to SomaLogic, Dr. Williams was at Pfizer in the UK and the USA as a clinical triallist in Translational Medicine, and subsequently as VP, Global Clinical Technology. He sat on the National Advisory Council for the National Institute of Biomedical Imaging and Bioengineering, the Executive Committee for the FNIH Biomarkers Consortium, and worked with FDA and PhRMA on developing evidentiary standards for biomarker qualification. Dr. William’s medical training was in London, at Charing Cross and Westminster Medical School, followed by a PhD in medicine/physiology at the same institution and training in Radiology at the University of Newcastle Upon Tyne. Steve is co-inventor on 26 proteomics patents and author/coauthor on multiple foundational proteomics manuscripts.

Justin McAnear

CFO

Mr. McAnear serves as the company’s Chief Financial Officer. He brings over 25 years of operational and financial leadership experience across various sectors and was instrumental in taking 10x Genomics public in 2019, serving as its CFO for over five years. Mr. McAnear served for over 3 years as Tesla’s VP of Worldwide Finance and Operations, supporting landmark initiatives such as the Model X and Model 3 launches and Solar City acquisition.  He also held various roles at Apple and J&J earlier in his career and served as a naval officer and aviator for over 9 years.