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Piromelatine

Piromelatine, also known as Neu-P11, is a drug currently being studied in clinical trials for its potential to treat mild Alzheimer’s Disease (AD). These trials aim to evaluate the safety, efficacy, and optimal dosage of Piromelatine in improving cognitive function and daily living activities in patients with mild dementia due to AD. The studies involve various assessments and measurements to determine the drug’s effects on memory, language, attention, and overall quality of life for patients with this challenging condition.

Table of Contents

What is Piromelatine?

Piromelatine, also known as Neu-P11, is an investigational drug being studied for the treatment of mild dementia due to Alzheimer’s Disease (AD). It is currently undergoing clinical trials to determine its safety and effectiveness in improving cognitive function and daily activities in patients with mild Alzheimer’s Disease[1][2].

How Piromelatine Works

While the exact mechanism of action is not fully described in the provided clinical trial data, Piromelatine is being studied for its potential to improve cognitive performance and daily functioning in patients with mild Alzheimer’s Disease. It is also being investigated for its possible effects on sleep quality, which may be relevant to the overall management of Alzheimer’s symptoms[1].

Clinical Trials

Two major clinical trials are currently investigating Piromelatine:

  1. A Phase 2 study (ReCOGNITION) testing different doses (5 mg, 20 mg, and 50 mg) against a placebo for 26 weeks[1].
  2. A confirmatory study focusing on the 20 mg dose for 26 weeks, followed by a 12-month extension period to explore potential long-term effects[2].

These trials aim to determine the most effective dose, assess safety and tolerability, and evaluate the drug’s impact on cognitive function and daily activities in patients with mild Alzheimer’s Disease.

Dosage and Administration

In the clinical trials, Piromelatine is administered as follows:

  • Taken orally as tablets
  • Dosage ranges from 5 mg to 50 mg, with 20 mg being a focus in the confirmatory study
  • Administered once daily, typically 1-2 hours before bedtime (preferably between 9:00 PM and 11:00 PM)
  • Taken after food consumption

It’s important to note that these dosage instructions are specific to the clinical trials and may change based on the study results[1][2].

Effectiveness Measures

The clinical trials are using several tools to measure the effectiveness of Piromelatine:

  • ADAS-cog14 (Alzheimer’s Disease Assessment Scale-Cognitive Subscale): This test measures memory, language, and other cognitive abilities. A lower score indicates less severe impairment[1][2].
  • ADCS-MCI-ADL (Alzheimer’s Disease Cooperative Study/Activities of Daily Living Scale): This scale evaluates a patient’s ability to perform daily activities. A higher score indicates better functioning[1].
  • CGIC (Clinical Global Impression of Change): This assessment measures overall change in a patient’s condition as observed by a clinician[1][2].
  • MMSE (Mini-Mental State Examination): This brief test assesses cognitive function, with a higher score indicating better cognitive performance[2].
  • NPI (Neuropsychiatric Inventory): This tool evaluates behavioral and psychological symptoms associated with dementia[1].
  • PSQI (Pittsburgh Sleep Quality Index): This questionnaire assesses sleep quality, with lower scores indicating better sleep[1].

Safety and Side Effects

The clinical trials are closely monitoring the safety and tolerability of Piromelatine. Safety measures include:

  • Blood pressure and heart rate monitoring
  • ECG (electrocardiogram) to check heart function
  • Blood tests to assess overall health
  • Tracking of adverse events (side effects)

Specific side effects are not detailed in the provided information, as the trials are ongoing. The safety profile will be better understood once the studies are completed[1][2].

Who Can Benefit from Piromelatine?

Based on the clinical trial criteria, Piromelatine is being studied in patients with the following characteristics:

  • Diagnosed with mild dementia due to Alzheimer’s Disease for at least 6 months
  • Score between 20 and 27 on the Mini-Mental State Examination (MMSE), indicating mild cognitive impairment
  • In one study, participants must be non-carriers of a specific genetic polymorphism (2:107,510,000-107,540,000)
  • Have a committed caregiver who can assist with the study requirements

It’s important to note that Piromelatine is still an investigational drug and is not yet approved for general use. Its potential benefits and risks are still being evaluated in clinical trials[1][2].

Aspect Details
Drug Name Piromelatine (Neu-P11)
Condition Studied Mild Alzheimer’s Disease (AD)
Study Design Randomized, double-blind, placebo-controlled
Dosages Tested 5 mg, 20 mg, 50 mg
Administration Oral tablets, once daily before bedtime
Primary Outcomes Changes in cognitive function (ADAS-cog14, cNTB)
Secondary Outcomes Activities of daily living, global impression of change, safety and tolerability
Study Duration 26 weeks (with potential 12-month extension)
Key Assessments ADAS-cog14, MMSE, ADCS-iADL, CGIC, safety monitoring

FAQ

  • What is Piromelatine and how is it being studied? Piromelatine, also known as Neu-P11, is a drug being investigated for the treatment of mild Alzheimer's Disease. It is being studied in clinical trials to determine its safety, effectiveness, and optimal dosage for improving cognitive function and daily activities in patients with mild dementia due to AD.
  • What are the main goals of the Piromelatine clinical trials? The main goals of the Piromelatine clinical trials are to assess its effects on cognitive performance, safety, and tolerability in patients with mild dementia due to Alzheimer's Disease. The studies also aim to evaluate its impact on daily living activities and overall quality of life for patients.
  • How is Piromelatine administered in these trials? In the clinical trials, Piromelatine is administered orally as tablets. Patients are typically instructed to take the medication once daily, usually 1-2 hours before bedtime (preferably between 9:00 PM and 11:00 PM) and after food consumption.
  • What are some of the key measurements used in these trials? The trials use various assessments to measure the effects of Piromelatine, including the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14), the Computerized Neuropsychological Test Battery (cNTB), Activities of Daily Living scales, and the Clinical Global Impression of Change (CGIC). These tests help evaluate changes in cognitive function, daily activities, and overall clinical improvement.
  • How long do these clinical trials typically last? The duration of the clinical trials varies, but they generally last several months. For example, one study includes a 26-week double-blind treatment period, while another includes a 26-week initial phase followed by a 12-month open-label extension period, for a total of 18 months of treatment.

Ongoing Clinical Trials on Piromelatine

  • Study on the Effects and Safety of Piromelatine for Patients with Idiopathic Rapid Eye Movement Behavior Disorder (iRBD)

    Not recruiting

    1 1
    Investigated drugs:
    Austria

Glossary

  • Alzheimer's Disease (AD): A progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability to carry out simple tasks. It is the most common cause of dementia in older adults.
  • Piromelatine (Neu-P11): An investigational drug being studied for its potential to treat mild Alzheimer's Disease by improving cognitive function and daily living activities.
  • Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs. In these trials, it's a tablet that looks identical to the Piromelatine tablet but contains no active ingredient.
  • ADAS-cog14: Alzheimer's Disease Assessment Scale-Cognitive subscale, a test used to measure the severity of the most important symptoms of AD, including disturbances of memory, language, praxis, attention, and other cognitive abilities.
  • Mini-Mental State Examination (MMSE): A brief assessment tool used to screen for cognitive impairment and measure cognition over time in elderly patients.
  • Activities of Daily Living (ADL): Routine activities that people tend to do every day without needing assistance, such as eating, bathing, dressing, toileting, walking, and continence.
  • Clinical Global Impression of Change (CGIC): A measure used by clinicians to evaluate a patient's response to treatment, assessing overall clinical change in cognitive, functional, and behavioral performance.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving a placebo or standard treatment.
  • Randomized controlled trial: A study design that randomly assigns participants into an experimental group or a control group to minimize bias and ensure the validity of the results.

References

  1. https://clinicaltrials.gov/study/NCT02615002
  2. https://clinicaltrials.gov/study/NCT05267535