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Melatonin Receptor Agonist

Piromelatine for Alzheimer's Disease

Phase 2 & 3
Recruiting
Research Sponsored by Neurim Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 60 85 years (inclusive).
Participant is an outpatient living at home or in an assisted living facility and is willing to attend all planned visits during the study.
Timeline
Screening 2 days
Treatment 20 months
Follow Up 2 weeks
Awards & highlights

Summary

This trial tests piromelatine, a pill taken before bed, in people with mild Alzheimer's who lack a specific genetic variation. The goal is to see if it can improve brain function and slow down dementia progression.

Who is the study for?
This trial is for adults aged 60-85 with mild dementia due to Alzheimer's, living at home or in assisted living, who can attend all visits and have a reliable study partner. They must be stable on current AD medications if used, not carriers of specific genetic polymorphisms, able to spend time in daylight daily, and agree to contraception if applicable. Exclusions include severe other diseases or conditions that could interfere with the study.
What is being tested?
The trial tests Piromelatine 20 mg against a placebo in participants with mild Alzheimer's-related dementia. It aims to see how well Piromelatine works compared to a placebo by measuring cognitive function after 26 weeks using the AD Assessment Scale cognitive subscale (ADAS-cog14). Participants are randomly assigned either the drug or placebo.
What are the potential side effects?
While side effects specific to Piromelatine aren't detailed here, common side effects for similar treatments may include sleep disturbances, mood changes, headaches, dizziness and gastrointestinal issues like nausea. Patients will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 85 years old.
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You live outside of the hospital and are able to attend all scheduled visits for the study.
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I have a reliable partner to help me throughout the study.
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I have signed the consent form and understand what participating in the study involves.
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I have experienced a decline in my thinking skills for over a year.
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I have been on stable Alzheimer's medication for at least 6 months.

Timeline

Screening ~ 2 days
Treatment ~ 20 months
Follow Up ~2 weeks
This trial's timeline: 2 days for screening, 20 months for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog 14)
Secondary study objectives
ADCS-Clinical Global Impression of Change (CGIC)
Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL)
Clinical Safety - descriptive statistics for Adverse Events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Piromelatine 20 mgExperimental Treatment1 Intervention
Piromelatine 20 mg tablets once daily taken before going to bed, preferably between 2100h and 2300h, and after food consumption.
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo tablets, with identical features to the piromelatine tablets, will be used as control treatment

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease include cholinesterase inhibitors, NMDA receptor antagonists, and melatonin receptor agonists. Cholinesterase inhibitors, such as donepezil, work by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning, thereby improving communication between nerve cells. NMDA receptor antagonists, like memantine, regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Melatonin receptor agonists and serotonin receptor modulators, such as Piromelatine, aim to regulate circadian rhythms and improve sleep, which are often disrupted in Alzheimer's patients. These treatments are crucial as they address different aspects of the disease, potentially improving cognitive function, behavior, and quality of life for patients.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Syneos HealthOTHER
175 Previous Clinical Trials
68,174 Total Patients Enrolled
Neurim Pharmaceuticals Ltd.Lead Sponsor
16 Previous Clinical Trials
2,099 Total Patients Enrolled
Lon Schneider, MDStudy ChairKeck School of Medicine of USC, Los Angeles, CA
4 Previous Clinical Trials
1,207 Total Patients Enrolled

Media Library

Piromelatine 20 mg (Melatonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05267535 — Phase 2 & 3
Alzheimer's Disease Research Study Groups: Piromelatine 20 mg, Placebo
Alzheimer's Disease Clinical Trial 2023: Piromelatine 20 mg Highlights & Side Effects. Trial Name: NCT05267535 — Phase 2 & 3
Piromelatine 20 mg (Melatonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267535 — Phase 2 & 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05267535 — Phase 2 & 3
~67 spots leftby Oct 2025