Study of Daridorexant for Treating Insomnia in Patients with Mild Cognitive Impairment and Mild to Moderate Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called daridorexant on patients who have trouble sleeping, known as insomnia, and who also have mild cognitive impairment or mild to moderate Alzheimer’s disease. The purpose of the study is to evaluate how well daridorexant helps improve sleep in these patients. Participants in the study will take either daridorexant or a placebo, which looks like the real medication but does not contain the active ingredient.

The study will involve taking the medication in the form of film-coated tablets by mouth. The treatment period will last for several months, during which the participants’ sleep patterns will be monitored. This will help researchers understand how the medication affects the total sleep time and other sleep-related factors. The study will also look at how the medication impacts other aspects of health, such as mood, memory, and overall quality of life.

Throughout the study, participants will undergo various assessments to track changes in their sleep and cognitive functions. These assessments may include sleep studies using a method called polysomnography, which records brain waves, oxygen levels, heart rate, and breathing during sleep. The study aims to provide valuable insights into the potential benefits of daridorexant for improving sleep and related symptoms in patients with insomnia and Alzheimer’s disease.

1 joining the trial

Upon joining the clinical trial, participants will be informed about the study’s purpose, which is to evaluate the effectiveness of the medication daridorexant in treating insomnia in individuals with mild cognitive impairment and mild to moderate Alzheimer’s disease.

Participants will be required to provide informed consent, confirming their understanding and willingness to participate in the study.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

A baseline sleep study, known as polysomnography, will be conducted to measure total sleep time and other sleep parameters.

3 medication administration

Participants will be randomly assigned to receive either the active medication daridorexant 50 mg or a placebo. The placebo is a tablet that looks identical to the active medication but does not contain the active substance.

The medication or placebo will be taken orally once daily, following the instructions provided by the study team.

4 ongoing monitoring

Throughout the trial, participants will be monitored regularly to assess the effects of the medication on sleep patterns and overall health.

Participants will be asked to complete sleep diaries and questionnaires to report their sleep quality and any changes in daytime functioning.

5 follow-up assessments

At the end of each study period (Month 1 and Month 2), participants will undergo follow-up assessments, including polysomnography, to evaluate changes in sleep patterns.

Additional assessments may include cognitive tests and questionnaires to measure mood, alertness, and quality of life.

6 completion of the trial

Upon completion of the trial, participants will have a final assessment to review their overall experience and any changes in their condition.

Participants will be informed about the next steps and any potential opportunities for continued treatment or follow-up studies.

Who Can Join the Study?

Age between 60 and 85 years old.
Must be an outpatient, meaning you are not staying overnight in a hospital.
Have complaints about sleep, such as not being satisfied with the amount or quality of sleep, even though you have enough time to sleep. This should happen at least 3 nights a week for at least 3 months.
Your total sleep time should cause significant problems or difficulties during the day.
Your total sleep time, as estimated by an interview and sleep diary, should be less than 6 hours on at least 3 nights a week for at least 1 month before the screening.
Have an Insomnia Severity Scale (ISI) score of 15 or higher. The ISI is a questionnaire that measures the severity of insomnia.
At the start of the study, your sleep study (polysomnography) should show total sleep time of less than 6 hours and wake time after sleep onset (WASO) of more than 1 hour. Polysomnography is a test that records your brain waves, oxygen level, heart rate, and breathing during sleep.
Have a diagnosis of MCI (Mild Cognitive Impairment) and early-stage AD (Alzheimer’s Disease) according to specific criteria, including certain brain changes seen in tests like MRI.
Have a Mini-Mental State Examination (MMSE) score between 12 and 26. The MMSE is a test that measures cognitive impairment.
Have a Clinical Dementia Rating (CDR) score between 0.5 and 2. The CDR is a scale used to characterize six domains of cognitive and functional performance.
If you are taking certain central nervous system (CNS) drugs, such as anticholinesterase drugs (like rivastigmine, donepezil, galantamine) or memantine, the dose must be stable for at least 3 months.

Who Cannot Join the Study?

Patients who have a different sleep disorder other than insomnia cannot participate. Insomnia is a condition where a person has trouble falling asleep or staying asleep.
Patients with severe forms of Alzheimer’s Disease are not eligible. Alzheimer’s Disease is a brain disorder that affects memory and thinking skills.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to give their own consent or understand the study details are excluded.
Patients with certain medical conditions that might interfere with the study results are not allowed to join.
Patients who are currently participating in another clinical trial are not eligible.
Patients who have a history of substance abuse or dependency are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have allergies or reactions to the study medication are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Montpellier	Montpellier	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2023

Trial locations

Investigated drugs:

Daridorexant

Daridorexant is a medication being studied for its potential to help people with insomnia, especially those who have mild cognitive impairment or mild to moderate Alzheimer’s disease. Insomnia is a condition where people have trouble sleeping, and this medication aims to improve the total amount of sleep a person gets. It works by targeting specific receptors in the brain that are involved in the sleep-wake cycle, helping to promote better sleep. The goal of the trial is to see if taking this medication can increase the total sleep time for people who have difficulty sleeping due to their cognitive conditions.

Insomnia Disorder – Insomnia Disorder is characterized by difficulty in falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It often leads to daytime fatigue, mood disturbances, and impaired cognitive function. The condition can be acute, lasting a few days or weeks, or chronic, persisting for a month or longer. Insomnia can be caused by stress, irregular sleep schedules, poor sleeping habits, mental health disorders, or other medical conditions. Over time, it can affect overall health and quality of life. The progression of insomnia can vary, with some individuals experiencing intermittent episodes and others having persistent symptoms.

Alzheimer’s Disease – Alzheimer’s Disease is a progressive neurodegenerative disorder that affects memory, thinking, and behavior. It is the most common cause of dementia among older adults. The disease begins with mild memory loss and confusion, eventually leading to severe cognitive decline and loss of ability to carry out daily activities. As it progresses, individuals may experience disorientation, mood and behavior changes, and difficulty speaking, swallowing, and walking. The exact cause is not fully understood, but it involves the buildup of amyloid plaques and tau tangles in the brain. The progression of Alzheimer’s Disease varies, but it typically worsens over several years.

Trial ID:

2023-503301-10-00

Protocol code:

RECHMPL22_0529

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Daridorexant for Treating Insomnia in Patients with Mild Cognitive Impairment and Mild to Moderate Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?