NCT05267535

Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease

Randomized, Delayed Start, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study of Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Neurim Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimer's disease is conducted as a confirmatory, randomized efficacy and safety study in participants who are 2:107,510,000-107,540,000 polymorphism non-carriers (N=225). Participants will be randomized in a 1:1 allocation ratio to receive either piromelatine 20 mg or placebo for 26 weeks. Medication is to be administered orally, one tablet daily, taken 1-2 hours before going to bed (preferably between 2100h and 2200h) and after food. To differentiate between symptomatic effects and potential disease modifying effects of piromelatine, there will be a delayed-start open-label extension period of 12 months treatment wherein placebo-treated participants will be treated with piromelatine (20 mg daily) and the piromelatine-treated patients will be continued. This exploratory phase is aimed to continue randomized assignment of piromelatine treatment, long-term (18 months overall) to evaluate its potential disease modifying effect compared to patients in the placebo-randomized group who started the treatment after a 6-month delay. The primary efficacy analysis (blinded) is planned after completion of the 26 weeks double blind period. If efficacy is not confirmed, then the study will be ended without completing the extension period

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Piromelatine 20 mg	Tablets
DRUG	Placebo	Tablets

Timeline

• Start date: 2022-05-12
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-03-04
• Last updated: 2024-06-21

Locations

37 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study