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 aged 50 to 84 years old at the time of screening.
• Women must either be unable to become pregnant (due to surgical procedures such as hysterectomy, removal of ovaries, or removal of fallopian tubes, or because they have gone through menopause with no period for more than 12 months) or must have a negative pregnancy test at screening.
• People who have been diagnosed with mild Alzheimer's dementia, confirmed through medical records.
• People whose vision and hearing are good enough to take part in all study activities.
• People who are able to swallow and take tablets or capsules by mouth.
• People who are able to attend all required study visits as scheduled.
• People who have a trusted person (such as a family member or carer) who spends at least 10 hours per week with them directly, is willing to come to certain clinic visits, help supervise the taking of study medication, and be available for phone calls or interviews.
• People whose memory test score (called the MMSE) falls between 20 and 26 at the first screening visit.
• People who have had a brain CT or MRI scan within the past 12 months showing no significant abnormalities that could separately explain dementia — or who are willing to have one done before starting the trial.
• People whose Hachinski ischemic score (a measure used to assess stroke-related factors) is below 4 (confirm with trial site).
• People whose geriatric depression scale score is below 10 (a screening tool for depression in older adults).
• People who have proof of chickenpox (varicella) vaccination before the first dose of study drug is given.
• People who are assessed by the study doctor as able to give informed consent themselves, or who have a legally authorised representative to give consent on their behalf — and whose study partner also signs the consent form.
• People with no active suicidal thoughts, as assessed by a standard rating scale used in the trial.
• People with stable prostate cancer may be considered for inclusion, at the discretion of the trial's medical monitor.
• People who have been taking certain Alzheimer's antibody medications (such as lecanemab or donanemab) for more than 6 months, or who stopped taking them more than 6 months ago, may be considered if all other criteria are met.

Who may not be able to join:

• People currently taking any of the following medications: cancer treatments or immune-suppressing drugs (such as natalizumab or rituximab), amiodarone, bishydroxycoumarin, chloramphenicol, cimetidine, fluconazole, fluvastatin, miconazole, phenylbutazone, sulphinpyrazone, sulphadiazine, sulphamethizole, sulfamethoxazole, sulphaphenazole, trimethoprim, or zafirlukast.
• People who currently have an active infection, including but not limited to shingles, herpes, bronchitis, sinus infections, upper respiratory infections, or fungal skin infections.
• People who received an mRNA COVID-19 vaccine less than 3 months before the first dose of the study drug.
• People who have a current or recent (within the past 3 years) neurological or psychiatric condition that could separately contribute to dementia, such as epilepsy, Parkinson's disease, seizure disorder, or a head injury with loss of consciousness.
• People who meet the clinical criteria for a major psychiatric disorder such as psychosis, major depression, or bipolar disorder.
• People with a known or self-reported history of alcohol or substance misuse within the past three years.
• People whose living situation means no study partner can reliably provide information about them.
• People with poorly controlled high blood pressure.
• People with a known heart conduction problem called atrioventricular (AV) block (types I, II, or III).
• People who have had a heart attack, or who have signs or symptoms of unstable heart disease or have had a heart procedure within the past year.
• People with severe lung disease (including COPD) that has required more than 2 hospital stays in the past year.
• People with untreated obstructive sleep apnoea.
• People with a thyroid condition, unless it has been well managed with treatment for at least 6 months before screening.
• People who have had an active cancer diagnosis (other than certain non-melanoma skin cancers) within the past five years.
• People with a very low lymphocyte count (a type of white blood cell) currently or within the past two years.
• People with a very low neutrophil count (another type of white blood cell) currently or within the past two years.
• People with a history of, or current, blood clots (including deep vein thrombosis).
• People with significant liver or kidney disease, including hepatitis B or C, or certain abnormal blood test results relating to liver or kidney function.
• People with significant blood disorders, unexplained anaemia, or a low platelet count at screening.
• People who have taken part in another clinical drug trial within the past 30 days, or within five half-lives of that drug — whichever is longer.
• People who are unwilling or unable to have a CT or MRI brain scan.
• People where the investigator believes participation would not be in their best interest.
• People with a specific genetic variation called CYP2C9*3/*3 (confirm with trial site).

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