Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from the 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 aged between 60 and 85 years old (inclusive) of any gender
• People who have been diagnosed with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, based on updated 2024 diagnostic guidelines
• People whose memory and overall thinking assessments at the start of the study fall within specific score ranges on standard tests used by doctors (confirm with trial site for exact scores)
• People whose memory test score is 22 or higher on a standard thinking and memory test called the MMSE
• People with a body weight that falls within a healthy range relative to their height — specifically, a BMI greater than 17 and no more than 35
• People who have had a gradual and ongoing decline in memory for at least 6 months before joining, confirmed by someone who knows them well
• People who have a specific blood marker called p-tau 217 that tests positive, indicating signs of Alzheimer's disease in the brain
• People who have had a special brain scan (amyloid PET scan) that shows a positive result, indicating the presence of amyloid plaques in the brain
• People who have a designated support person (such as a family member or close friend) who is willing and able to spend at least 8 hours per week with them during the study, provide information about them, and sign a separate consent form
• People who are already taking Alzheimer's medications (such as cholinesterase inhibitors or memantine) and have been on a stable dose for at least 12 weeks before the study begins
• People who are willing and able to use appropriate contraception during the study and for 90 days after the last dose of the study medication (specific requirements vary depending on gender and reproductive status — confirm with trial site)
• People who are able to read and understand the consent form and agree to take part voluntarily (or whose legal representative does so on their behalf)
• People who are fluent in the language used at the trial site
• People who are willing and able to follow all study requirements

Who may not be able to join:

• People with a history of a brain infection or a serious traumatic brain injury
• People who have had significant heart problems — such as severe coronary heart disease, serious heart failure, or atrial fibrillation — in the six months before joining
• People who have had most types of cancer in the last three years (some exceptions, such as certain low-risk skin cancers, may apply — confirm with trial site)
• People with serious blood disorders such as aplastic anaemia, lymphoma, or leukaemia
• People with stomach ulcers, bowel blockages, or other conditions that may affect how oral medication is absorbed
• People with a neurological condition other than Alzheimer's disease that may also be causing thinking or memory problems
• People with a psychiatric diagnosis or significant mental health symptoms — such as hallucinations, major depression, or delusions — that could interfere with the study
• People who have had a mini-stroke (TIA), stroke, or seizure in the 12 months before joining
• People whose results on a specific brain blood vessel health assessment at screening are above a certain level (confirm with trial site)
• People whose heart rhythm test (ECG) shows certain abnormalities, such as an irregular or unusually slow heartbeat
• People who score 8 or higher on a standard depression screening tool for older adults (the Geriatric Depression Scale)
• People who cannot have an MRI scan — for example, because they have a pacemaker or certain metal implants in their body
• People who are allergic to the dye (tracer) used in PET scans
• People whose brain MRI scan shows signs that suggest a type of dementia other than Alzheimer's disease
• People whose brain MRI scan shows a single brain bleed larger than 10mm, or signs of brain swelling (angioedema)
• People with a bleeding disorder that is not well controlled, or whose blood clotting results fall outside acceptable ranges
• People with thyroid hormone levels that are outside the normal range
• People with vitamin B12 levels that are below the normal range, or who are currently taking vitamin B12 supplements
• People who test positive for HIV, active syphilis, Hepatitis B, or Hepatitis C
• People with any other significant health findings at screening that the trial doctor considers unsafe
• People with a known or suspected history of drug or alcohol misuse
• People with serious or unstable health conditions — such as poorly controlled high blood pressure, poorly controlled diabetes, or significant heart, lung, liver, kidney, or nervous system disease
• People who have previously taken certain Alzheimer's disease-modifying treatments (such as lecanemab or donanemab) or other formulations of a drug called edaravone
• People who have a surgical procedure requiring general anaesthesia planned during the study period
• People with significant vision, hearing, reading, comprehension, or physical difficulties that would prevent them from completing the study's thinking and memory tests
• People with serious active liver disease, or whose liver function blood test results are significantly above the normal range
• People with serious active kidney disease or whose kidney function test results fall outside acceptable ranges
• People with a serious illness where life expectancy is estimated to be less than 2 years
• People who have recently expressed certain types of suicidal thoughts or behaviours, or who have been hospitalised for suicidal behaviour in the past 5 years
• People who are allergic to edaravone or to certain ingredients used in the study medication (people with asthma may be at higher risk and will be carefully assessed — confirm with trial site)
• People who have had major surgery within 4 weeks before joining
• People who are currently participating in, or have participated in, another clinical trial within 30 days before joining
• People who previously stopped taking cholinesterase inhibitors or memantine due to safety concerns and are unwilling or unable to take them again
• Female participants who are pregnant, breastfeeding, planning to become pregnant, or unwilling to use contraception
• People who the trial doctor considers unsuitable for any other reason

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