{"artifact":{"id":"experiment-exp-wiki-experiments-biomarker-guided-therapy-sequencing-ad","artifact_type":"experiment","entity_ids":null,"title":"Biomarker-Guided Sequential Therapy Selection in Alzheimer's Disease","quality_score":0.675,"created_by":"crosslink-v2","provenance_chain":null,"content_hash":null,"metadata":{"source":{"type":"manual","source_name":"wiki","extracted_by":"backfill_v1","extraction_date":"2026-04-16T01:00:16.901137Z"},"summary":"# Biomarker-Guided Sequential Therapy Selection in Alzheimer's Disease\n## Background and Rationale\nAlzheimer's disease (AD) represents a complex neurodegenerative disorder with heterogeneous pathophysiology, necessitating personalized therapeutic approaches. Current treatment strategies employ a one-size-fits-all paradigm that fails to account for individual patient variations in disease progression, biomarker profiles, and therapeutic responsiveness. This biomarker-guided sequential therapy sel","entities":{"genes":["APOE/BDNF/PPARGC1A"],"diseases":["Alzheimer's Disease"]},"model_system":"human","_schema_version":1,"experiment_type":"clinical","primary_outcome":"Superior cognitive preservation (CDR-SB score change) at 18 months in biomarker-guided sequential therapy group compared to standard-of-care control, with target effect size of 30% reduction in cognitive decline rate.","methodology_notes":"Phase 1 (Months 1-3): Recruit 400 AD patients (mild-moderate stages) across 8 clinical sites. Obtain comprehensive baseline biomarker profiles including CSF amyloid-beta42, phosphorylated tau, neurofilament light chain via lumbar puncture, plasma p-tau181/217 via Simoa assays, and 18F-flortaucipir PET imaging. Conduct neuropsychological assessments using ADAS-Cog13, CDR-SB, and MMSE. Phase 2 (Months 4-6): Randomize participants 1:1 to biomarker-guided therapy selection versus standard care. Apply machine learning algorithm incorporating biomarker data, APOE genotype, and cognitive profiles to assign optimal therapy: amyloid-targeting (aducanumab/lecanemab), tau-directed (semorinemab), cholinesterase inhibitors (donepezil/rivastigmine), or combination protocols. Control group receives standard cholinesterase inhibitor therapy. Phase 3 (Months 7-18): Implement assigned therapies with standardized dosing protocols. Conduct biomarker reassessments every 3 months using blood-based assays an","replication_status":"single_study","extraction_metadata":{"backfill_at":"2026-04-16T01:00:16.901142","needs_review":true,"extraction_notes":"Backfilled from wiki source (no PMID 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