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Melatonin Receptor Agonist
Piromelatine for Alzheimer's Disease
Phase 2 & 3
Waitlist Available
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
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 belowSelect...
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 days7 visits
Treatment ~ 20 months7 visits
Follow Up ~ 2 weeks7 visits
Screening ~ 2 days
Treatment ~ 20 months
Follow Up ~2 weeks
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 moreTrial 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
176 Previous Clinical Trials
68,430 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be willing to limit alcohol intake, avoid caffeine overconsumption, and maintain a regular lifestyle during the study. You must also not have a history of suicidal behavior or present a serious risk of suicide.My mental abilities have been getting worse over the last year.I have been diagnosed with mild dementia.I am a woman who has not had a period in at least 2 years or I am surgically sterile.I and my study partner are fully vaccinated for COVID-19, including any booster doses.I chose not to have genetic testing for specific DNA changes and APOE4.My dementia is not caused by Alzheimer's disease.I have a history of severe agitation that required medical treatment.I have had a serious infection like neurosyphilis, meningitis, or encephalitis.I have a specific heart condition or my ECG shows a prolonged QTc interval.You have other serious medical conditions that might affect your ability to participate in the trial, according to the doctor.I haven't been in a drug trial for 3 months, or an antibody study for AD for 6 months, and I've never had an AD vaccine.My medication doses have been stable for at least 4 weeks, and if on antidepressants, for 3 months.I've been on stable Alzheimer's medication for at least 6 months.I have been on stable Alzheimer's medication for at least 6 months.You live outside of the hospital and are able to attend all scheduled visits for the study.You need to have a certain level of cognitive function, which will be tested with a questionnaire. Your score needs to be between 20 and 26, and it shouldn't change more than three points between tests.I am using or willing to use two forms of birth control if applicable, or I am surgically sterile.You have a history of using benzodiazepines or other sedative drugs for more than 3 months.I have an MRI or CT scan from the last year confirming my Alzheimer's diagnosis without other major health issues.I have been using sedatives or similar drugs regularly for the last 2 weeks.I haven't taken melatonin or similar sleep aids in the last 2 weeks.I do not have serious neurological conditions other than Alzheimer's disease.My cancer has not been in remission for more than 5 years, except for certain skin, breast, cervical, or prostate cancers.My study partner and I can read and write in English or Spanish and can see, hear, and move well enough for tests.I carry a specific genetic variation.My heart rate is consistently below 50 or above 100 bpm.I do not have severe liver, kidney issues, or other diseases that could affect the study.I have a reliable partner to help me throughout the study.I have an MRI or CT scan from the last year confirming my Alzheimer's diagnosis without other major health issues.I have signed the consent form and understand what participating in the study involves.I have experienced a decline in my thinking skills for over a year.I haven't taken acetylcholinesterase inhibitors for 3 months and won't start them during the first 26 weeks of the trial.I have passed a drug test for benzodiazepines and opiates, or only used them intermittently and not within 4 days of my visit.I am between 60 and 85 years old.I have signed the consent form and understand what it means.I am between 60 and 85 years old.I have a reliable partner to help me during the study.My BMI is either above 35 or below 18.I have severe pain that might stop me from sleeping.I have been diagnosed with mild dementia.You have symptoms that match the research criteria for probable Alzheimer's disease.You have a mental health condition, such as schizophrenia or bipolar disorder, that may interfere with your ability to participate in the trial. You also cannot have had a substance abuse problem within the past 2 years or major depression.I can commit to 2 hours of daylight exposure daily.I have had serious heart, hormone, stomach, lung, or joint issues in the last 5 years.You have a known or suspected allergy to melatonin or drugs that work like melatonin.
Research Study Groups:
This trial has the following groups:- Group 1: Piromelatine 20 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 20 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05267535 — Phase 2 & 3