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Piromelatine for Alzheimer's Disease
Study Summary
This trialtests if a drug can help improve mild dementia in Alzheimer's patients who lack a certain gene.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Media Library
- 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.
- Group 1: Piromelatine 20 mg
- Group 2: Placebo
- 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.
Frequently Asked Questions
Are additional participants still being sought for this clinical trial?
"Affirmative. The information on clinicaltrials.gov confirms that this medical research is actively seeking out volunteers to participate in the study, which was first advertised on May 12th 2022 and recently updated on February 6th 2023. A total of 225 individuals need to be sourced from 6 sites for enrolment into the trial."
Does the age of 25 constitute a cutoff for potential participants in this experiment?
"As per the study's terms and conditions, individuals must be within a certain age range to qualify for this trial: no younger than 60 years old and not older than 85."
How many participants are sought after for this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on 12th May 2022 is actively recruiting participants. A total of 225 individuals need to be recruited from 6 distinct medical centres."
Does my profile meet the requirements to join this medical investigation?
"This clinical trial seeks 225 elderly individuals (aged 60-85) diagnosed with Alzheimer's disease. To qualify, participants must additionally meet the following conditions: possess legal capacity to provide informed consent; be accompanied by a study partner for all clinic visits and/or contactable by phone at designated times; demonstrate cognitive decline over 12 months; have undergone MRI/CT scan within past year verifying diagnosis of AD without comorbid pathologies as per Appendix 3; score between 20-26 on MMSE scale during screening period; fulfil NIA AA research criteria for probable AD according to McKhann et al.; take acetylcholinesterase"
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Velocity Clinical Research, Inc: < 24 hours
- Allied Biomedical Research Institute (Clinical Trials): < 24 hours
- Advance Medical Research Center: < 48 hours
Typically responds via
Average response time
- < 2 Days
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