Phase 2 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 who are male or female, of any race or ethnicity.
• People who are aged 65 years or older and able to give written consent to participate.
• People whose memory and thinking is rated as normal on a standard assessment called the Global Clinical Dementia Rating (CDR score of 0).
• People who are willing and able to take part in all study procedures.

Who may not be able to join:

• People with a history of symptoms linked to restless legs syndrome, narcolepsy, excessive daytime sleepiness disorders, or abnormal behaviours during sleep (such as sleepwalking).
• People without a breathing machine (PAP device) who score higher than 6 on a sleep apnoea screening questionnaire called the STOP-Bang.
• People with untreated sleep apnoea where a home sleep test shows 15 or more breathing interruptions per hour on average.
• People who use a PAP breathing machine for sleep apnoea but do not use it consistently (consistent use is defined as at least 4 hours per night on more than 70% of nights).
• People whose blood test results for certain brain-related proteins (plasma p-tau 217) fall at or below a specific level (confirm with trial site).
• People who have had a stroke.
• People with chronic kidney disease, defined as having kidney damage markers or a kidney function score below a certain level on blood tests.
• People with liver problems, shown by certain liver enzyme levels being more than twice the upper end of the normal range on blood tests.
• People living with HIV/AIDS.
• People with a history of drug or alcohol misuse in the past 6 months.
• People who regularly drink alcohol 3 or more days per week over the past 6 months, where regular drinking means having more than 2 alcoholic drinks within 3 hours of bedtime — though people who agree to reduce their alcohol intake during the study may not necessarily be excluded.
• People with any significant medical, behavioural, or psychiatric condition, or surgical history, that could affect safety or interfere with study assessments, as judged by the Principal Investigator (PI).
• People with any medical condition that the PI determines could increase risk, limit participation, or affect data collection — this may include heart disease requiring medication (except for well-controlled high blood pressure), lung disease, Type 1 diabetes, a neurological or psychiatric condition requiring medication, tobacco use, use of sedating medications, use of medications that interact with the study drug suvorexant (if those medications cannot be stopped), or abnormal results on safety blood tests.
• People with current thoughts of suicide.
• People who are currently pregnant or breastfeeding.
• People whose physical examination results are considered abnormal by the PI.
• People who have taken part in a clinical trial involving a study drug or device within the 30 days before enrolling in this study.
• People who plan to join another drug or device study before completing this study.
• For the optional spinal fluid collection (lumbar puncture) part of the study only: people who cannot safely have a lumbar puncture — for example, those on blood thinners, with a bleeding disorder, with an allergy to local anaesthetic (lidocaine) or disinfectant, or who have had prior surgery on the spine or nervous system.

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