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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04770220). This is a study registration, not published results. Lead sponsor: Alzheon Inc.. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 325 participants (ACTUAL). Conditions: Early Alzheimer's Disease. Interventions: DRUG: Experimental: ALZ-801; DRUG: Placebo Comparator: Placebo. Primary outcome measures: Primary Cognitive Efficacy Endpoint (ADAS-Cog13) , Baseline to Week 78; Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE) , Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks). Brief summary: This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.