{"id":"3e052d7c-4f06-5831-93b7-8218f607fb9c","stable_key":"e69ef6a0-0e23-5eac-aca1-cf333781b962:ino-scyllo-safety","predicate":"associated_with","statement":"The 1000- and 2000-mg twice-daily scyllo-inositol groups were stopped early after an imbalance of infections and deaths.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"027a26f8-fc34-5e42-ba36-de0e1d47c65e","mechanism_event_label":"Higher-dose safety findings belong to this stereoisomer and regimen, and should remain visible.","subject":{"id":"da2f3c6c-26e6-5337-a9a2-9f5e55931496","slug":"scyllo-inositol","display_name":"Scyllo-inositol","entity_type_key":"small_molecule"},"object":{"id":"f4df24e7-157d-5623-b993-50e8fdaa8401","slug":"infection-death-imbalance","display_name":"Trial infection and death imbalance","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"027a26f8-fc34-5e42-ba36-de0e1d47c65e","stable_key":"e69ef6a0-0e23-5eac-aca1-cf333781b962:ino-scyllo-safety-event","event_type":"observed_intervention","label":"Higher-dose safety findings belong to this stereoisomer and regimen, and should remain visible.","description":"The 1000- and 2000-mg twice-daily scyllo-inositol groups were stopped early after an imbalance of infections and deaths.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"da2f3c6c-26e6-5337-a9a2-9f5e55931496","slug":"scyllo-inositol","display_name":"Scyllo-inositol","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"f4df24e7-157d-5623-b993-50e8fdaa8401","slug":"infection-death-imbalance","display_name":"Trial infection and death imbalance","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/inositol-research/21917766.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"12c45a11b8cd0ee3075caa1f7572feae2130af237934a0be5f388322b64a1040\", \"start_char\": 0, \"end_char\": 1479, \"text_sha256\": \"12c45a11b8cd0ee3075caa1f7572feae2130af237934a0be5f388322b64a1040\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Randomized dose-ranging phase 2 trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Scyllo-inositol (ELND005) 250, 1000 or 2000 mg twice daily versus placebo for up to 78 weeks","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Distinct stereoisomer from myo-inositol. 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Higher-dose arms stopped for safety imbalance; biomarker changes do not establish clinical benefit.\nexposure: Scyllo-inositol (ELND005) 250, 1000 or 2000 mg twice daily versus placebo for up to 78 weeks\nevidence_span: {\"source_cache\": \"artifacts/inositol-research/21917766.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"12c45a11b8cd0ee3075caa1f7572feae2130af237934a0be5f388322b64a1040\", \"start_char\": 0, \"end_char\": 1479, \"text_sha256\": \"12c45a11b8cd0ee3075caa1f7572feae2130af237934a0be5f388322b64a1040\"}\n[ino-p21917766] A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. 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