MINDFuL trial highlighted at AD/PD
INmune Bio’s MINDFuL trial, which pairs anti‑inflammatory approaches with mindfulness for early Alzheimer’s, was featured as a successful model at AD/PD 2026 for targeting inflammation in early disease. The recognition matters because it spotlights integrative trial designs that combine biological and behavioral targets. (biospace.com)
Malú Gámez Tansey, Ph.D., Professor of Neurology at Indiana University, featured the MINDFuL Phase 2 data as a centerpiece of her AD/PD 2026 plenary in Copenhagen, March 17–21, 2026. (markets.financialcontent.com)) The MINDFuL study is registered as NCT05318976 and lists actual enrollment of 208 participants with a study start date of February 28, 2022 and primary/study completion on May 12, 2025. (clinicaltrials.gov)) Protocol documents and the medRxiv preprint show MINDFuL was a randomized, double‑blind, placebo‑controlled Phase 2 conducted across 35 centers in eight countries, enrolling ages 50–85 and using weekly subcutaneous dosing of XPro1595 for 24 weeks with the Early Mild Alzheimer’s Cognitive Composite (EMACC) as the primary cognitive endpoint. (medrxiv.org)) Company disclosures state the modified intent‑to‑treat population (mITT, n≈200) did not meet the trial’s primary EMACC endpoint, while a predefined subgroup of amyloid‑positive early AD patients with ≥2 inflammatory biomarkers (n≈100) showed treatment benefit on cognitive, behavioral and biological measures. (inmunebio.com)) INmune Bio describes XPro1595 (a selective soluble TNF neutralizer) as producing a “broad and consistent” pattern of efficacy in the biomarker‑enriched inflamed subgroup, language highlighted in the company’s AD/PD plenary materials. (inmunebio.com)) Following an End‑of‑Phase 2 meeting with the FDA, INmune Bio says it plans to advance an integrated Phase 2b/3 registrational program for XPro1595 in inflammatory‑enriched early AD patients, explicitly building on the MINDFuL dataset. (markets.ft.com)) INmune has submitted the MINDFuL results for peer review to npj Dementia and the company’s public statements indicate the data package underpins both the planned registrational strategy and the plenary framing at AD/PD 2026. (psychiatrictimes.com))
