Phase 4 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 60 and 85 years old
• People who are living at home (not in a care facility) and attending appointments as outpatients
• People who have been unhappy with the amount or quality of their sleep at least 3 nights per week for at least 3 months, even when they have had enough time and opportunity to sleep
• People whose poor sleep causes noticeable distress or affects their ability to function during the day
• People estimated to sleep less than 6 hours per night on at least 3 nights per week for at least 1 month before the screening visit
• People whose overnight sleep study (done at the start of the trial) shows less than 6 hours of total sleep and more than 1 hour of time spent awake during the night
• People who have been diagnosed with Mild Cognitive Impairment (MCI) or early-stage Alzheimer's disease, confirmed using specific medical tests including brain scans and certain markers in blood or spinal fluid
• People whose score on a standard memory and thinking test (called the MMSE) falls between 12 and 26
• People whose score on a standard dementia rating scale (called the CDR) falls between 0.5 and 2
• People who are taking certain brain- or mood-related medications (such as donepezil, memantine, antidepressants, or some pain medications), provided the dose has been stable for at least 3 months
• Male participants who are not surgically sterilised and are sexually active with a female partner who could become pregnant (no specific contraceptive requirement is stated for this trial)

Who may not be able to join:

• People who are significantly dependent on a caregiver for daily activities
• People living in a residential care facility or institution
• People who cannot read or write
• People who are unable to complete the neuropsychological (memory and thinking) tests required by the trial
• People who are unable to fill in a daily sleep diary
• People who have plans to be away from the region for an extended period that would prevent them from attending all required visits
• People who cannot be followed up for at least 2 months
• People with a history of narcolepsy (sudden sleep attacks) or cataplexy (sudden muscle weakness)
• People with a history of drug or alcohol misuse or addiction
• People with a history of a diagnosed psychiatric condition (as defined by DSM-5 standards), or any current psychiatric disorder confirmed by a specialist (confirm with trial site)
• People with moderate or severe liver problems
• People whose overnight sleep study shows a significant breathing disorder during sleep (more than 30 breathing interruptions per hour)
• People taking medications that are known to interfere with sleep or wakefulness patterns
• People taking sleeping tablets such as benzodiazepines, zolpidem, or zopiclone, or strong pain medications such as morphine or its derivatives
• People with a known allergy or sensitivity to the trial medication or any of its ingredients
• People taking certain other medications that interact with the trial drug, including CNS depressants, or drugs that strongly affect a liver enzyme called CYP3A4 (confirm specific medications with trial site)
• People currently taking part in another clinical trial or receiving another experimental treatment
• People in legally protected categories under French law, including those under legal guardianship, prisoners, and pregnant, recently delivered, or breastfeeding women
• People not covered by public health insurance
• People who have not given written consent to participate after being given adequate time to consider

Important: Always verify eligibility with the trial site directly before applying.