MINDFuL: a Multi‐center, Randomized, Double‐blind, Placebo‐controlled Phase 2 Clinical Trial of XPro1595 for Patients with Early Alzheimer's Disease and Biomarkers of Inflammation
Bibliographic record
Abstract
BACKGROUND: Dysfunctional inflammatory/immune processes are recognized as key contributors to the pathogenesis and progression of Alzheimer's Disease (AD). Tumor necrosis factor (TNF) is an apex inflammatory/immune signaling molecule that drives a range of immune functions that include neurotoxic neuroinflammation via soluble TNF and homeostatic maintenance and repair of neurons via transmembrane TNF. XPro1595 was designed to selectively neutralize soluble TNF while preserving transmembrane TNF resulting in a polarization of immune cell function to a reparative and neuroprotective state. METHOD: MINDFuL (NCT05318976, EUCT2023-505396-71-00) is a proof of concept, global, randomized, double-blind, placebo-controlled, Phase 2 clinical trial in participants with early AD and at least one biomarker of inflammation. Patients with biomarker confirmed mild cognitive impairment (MCI) due to AD or mild AD dementia (mAD) and biomarkers of inflammation were randomized 2:1 to receive either XPro1595 (1.0 mg/kg) or placebo, respectively, administered once-per-week by subcutaneous injection for 23-weeks. The primary outcome is the change from baseline on the Early Mild Alzheimer's Cognitive Composite (EMACC). Key secondary outcomes include change on the CDR-SB, E-Cog, and NPI-12. Additional secondary outcomes include ADCS-ADL, blood biomarkers of AD related pathology and neuroinflammation, and volumetric MRI. RESULT: MINDFuL enrolled 208 early AD patients, MCI (n =92) or mAD (n =116), 51% were female (n =106). All primary and secondary endpoints will be presented. The data will include cognitive and functional endpoints, a detailed safety analysis, blood biomarkers, and neuroimaging data. CONCLUSION: MINDFuL is a proof-of-concept study evaluating the efficacy and safety of XPro1595 (1.0 mg/kg/wk) in patients with early AD and biomarkers of inflammation. Detailed results of unblinded cognitive, functional, safety, and biomarker data will be presented.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".