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:

• Adults aged 50 to 85 years old at the time of signing the consent form
• People who have been diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease, confirmed using the 2024 NIA-AA diagnostic guidelines at the screening stage
• People whose overall CDR score (a standard measure of dementia severity) falls between 0.5 and 1.0 at screening, with a memory sub-score of at least 0.5
• People who score between 21 and 30 on the MMSE (a standard mental ability test) at screening
• People whose screening PET scan shows a positive result for amyloid (a protein associated with Alzheimer's disease) in the brain
• People who have a caregiver able to provide reliable information about their thinking and daily functioning, as assessed by the trial doctor
• People (or their legal representatives) who have voluntarily agreed in writing to take part in the study

Who may not be able to join:

• People whose memory or thinking problems are caused by something other than Alzheimer's disease — for example, vascular dementia, brain infections (such as HIV or syphilis), head injury, Huntington's disease, Parkinson's disease, brain tumours, thyroid problems, vitamin B12 or folate deficiency, or alcohol or drug misuse
• People whose screening tests show cognitive impairment linked to an underactive thyroid, or to vitamin B12 or folate deficiency
• People with a history of most cancers within the past five years (some exceptions may apply for certain skin cancers or cancers considered successfully treated — confirm with trial site)
• People with a history of alcohol or drug misuse within the two years before screening
• People who have had an unexplained loss of consciousness or a seizure in the past 52 weeks before screening
• People with certain serious or unstable heart conditions in the 24 weeks before the study start date, despite treatment (confirm with trial site)
• People who have had a serious or active infection requiring antibiotics or antiviral medication in the four weeks before the study start date
• People with a history of a major stroke, mini-stroke (TIA), epilepsy, or serious head injury involving loss of consciousness
• People known to be allergic to any ingredient in the trial medicine
• People with certain significant brain conditions identified on imaging scans within the past 52 weeks, such as multiple sclerosis, large brain tumours, major bleeding in the brain, or other serious neurological findings (confirm with trial site)
• People with high blood pressure that remains uncontrolled despite treatment (blood pressure of 160/100 mmHg or higher) at screening or study start
• People with dizziness or fainting when standing up (orthostatic hypotension), if the trial doctor believes this may affect study assessments
• People with poorly controlled diabetes (HbA1c above 9%) despite treatment
• People with a bleeding disorder involving a very low platelet count (below 50,000/mm³) despite treatment
• People with severe liver disease (classified as Child-Pugh class C)
• People whose blood test results at screening show significantly elevated liver enzymes, high bilirubin levels, or poor kidney function (confirm specific values with trial site)
• People with a specific heart rhythm measurement (QTcF interval) above 450 milliseconds for men or 470 milliseconds for women on an ECG at screening
• People with certain gut or digestive conditions that could affect how an oral medicine is absorbed, such as coeliac disease, Crohn's disease, or previous bowel surgery
• People with stomach or duodenal ulcers or other digestive conditions that the trial doctor believes could affect safety assessments
• People with uncontrolled serious mental health conditions such as major depression, schizophrenia, or bipolar disorder
• People who give certain concerning responses on a standard suicide risk questionnaire (C-SSRS items 4 or 5) at screening
• People who have recently used certain Alzheimer's disease treatments, including newer disease-modifying medicines (such as lecanemab or donanemab) within 12 weeks before screening
• People who have recently started or changed certain memory-related medicines (such as donepezil, galantamine, rivastigmine, or memantine), unless on a stable dose for at least 12 weeks before the study start — confirm details with trial site
• People who have recently used certain medicines that act on the brain or affect thinking, including some antidepressants, sedatives, antipsychotics, and related drugs, within 12 weeks before screening (confirm specific medicines with trial site)
• People who have recently used certain antihistamines or anticholinergic medicines that affect the brain, within 12 weeks before screening (some limited exceptions may apply — confirm with trial site)
• People who have participated in another clinical trial or used another experimental treatment within four weeks before the study start (or longer, depending on the medicine — a washout period may allow participation, confirm with trial site)
• People who have used certain specific medicines recently, including MAOIs, linezolid, opioid pain medicines, cyclobenzaprine, St. John's Wort, or a range of serotonin-affecting medicines (such as SSRIs, SNRIs, lithium, and others), within two weeks before the study start or longer — some exceptions at low doses may apply (confirm with trial site)
• People currently using stimulant medicines (such as methylphenidate or amphetamines) or dextromethorphan during the screening period
• People currently using certain medicines that strongly affect how the liver processes drugs (specific enzyme inhibitors and inducers — confirm with trial site)
• People who are unable to have MRI or PET scans
• Women who are pregnant or breastfeeding
• People who are capable of having children and are unwilling to use an accepted form of contraception from consent until 12 weeks after the last dose of the trial medicine (confirm accepted methods with trial site)
• People considered unsuitable for the study for any other reason, as judged by the trial doctor

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