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Piromelatine 20 mg / Alzheimer's Disease · Phase 2/3 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record documenting a planned randomized controlled trial of piromelatine 20 mg versus placebo in mild Alzheimer's disease, with ADAS-cog14 as the primary outcome at 26 weeks. The trial has been terminated and no results are posted in this registry record, so no efficacy or safety conclusions can be drawn.
Phase 2/3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimer's Disease; age from 60 Years; to 85 Years. Intervention: Piromelatine 20 mg. Compared with: Placebo — Placebo Comparator. n = 216. 37 sites: United States, Canada.
This is a clinical trial registry record documenting a planned randomized controlled trial of piromelatine 20 mg versus placebo in mild Alzheimer's disease, with ADAS-cog14 as the primary outcome at 26 weeks. The trial has been terminated and no results are posted in this registry record, so no efficacy or safety conclusions can be drawn.
No efficacy, safety, or comparative effect estimates are provided.
No clinical impact can be assessed, as this is a terminated trial with no posted results. Clinicians should await published outcomes or contact the sponsor (Neurim Pharmaceuticals Ltd.) for information on trial cessation and any findings.
A terminated Phase 2/3 RCT with no results posted; the registry record documents planned design and enrollment only, without outcome data or efficacy findings.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed, as this is a terminated trial with no posted results. Clinicians should await published outcomes or contact the sponsor (Neurim Pharmaceuticals Ltd.) for information on trial cessation and any findings.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05267535). This is a study registration, not published results. Lead sponsor: Neurim Pharmaceuticals Ltd.. Recruitment status: TERMINATED. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 216 participants (ACTUAL). Conditions: Alzheimer's Disease. Interventions: DRUG: Piromelatine 20 mg; DRUG: Placebo. Primary outcome measures: Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog 14) , 26 weeks. Brief summary: Randomized efficacy and safety study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimer's disease (AD) who are 2:107,510,000-107,540,000 polymorphism non-carriers with the primary objective to compare the effect of piromelatine to that of placebo on the AD Assessment Scale cognitive subscale (ADAS-cog14) at Week 26 of double-blind treatment.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.