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:

• Men and women between 55 and 90 years of age.
• People who have been diagnosed with mild cognitive impairment related to Alzheimer's disease, or mild to moderate Alzheimer's dementia, based on recognised international diagnostic guidelines.
• People whose score on a standard memory and thinking test (called the MMSE) falls between 17 and 30 out of 30.
• People whose score on a standard dementia severity scale (called the CDR) falls between 0.5 and 2.
• People who are willing to sign a consent form agreeing to take part in the study.
• People who have a close family member, partner, or informal carer who agrees to assist them throughout the study.
• People who have completed at least 6 years of formal education.
• People already taking certain Alzheimer's medications (cholinesterase inhibitors) are eligible, provided those medications were started at least 3 months before joining and the dose has been stable for at least 60 days. People taking memantine are eligible if it was started at least 4 months before joining and the dose has been stable for at least 3 months.

Who may not be able to join:

• People who are unwilling or unable to provide voluntary informed consent to participate.
• People who cannot read or write.
• Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective form of contraception (such as hormonal contraception, surgical sterilisation, an intrauterine device, or a condom used together with a vaginal spermicide).
• People who are currently participating in another clinical trial, or who have done so within the 3 months before the screening visit.
• People with liver failure, cirrhosis, or active liver disease, or those with a diagnosis of acute or chronic hepatitis of any cause.
• People with chronic kidney disease where kidney function (measured by GFR) falls below 60 ml/min/m² (confirm with trial site).
• People with abnormal liver test results, specifically where a liver enzyme called ALAT is more than twice the upper limit of the normal range.
• People with abnormally low levels of certain white blood cells — including low total white cell count, low granulocytes, or low lymphocytes — regardless of the cause.
• People experiencing severe agitation.
• People with an intellectual disability.
• People diagnosed with delirium (a state of sudden confusion) according to standard psychiatric diagnostic criteria.
• People diagnosed with other neurological or neurodegenerative conditions besides Alzheimer's disease, such as multiple sclerosis, Parkinson's disease, Huntington's disease, or those who have had a previous stroke.
• People whose brain scan (MRI) shows certain types of bleeding, multiple areas of damage from strokes, blood vessel abnormalities, aneurysms, bleeding between the brain and skull, or a condition called normal pressure hydrocephalus — with final decisions made by the trial doctor.
• People with a severe or poorly controlled physical health condition that could affect the study, such as cancer, serious heart, lung, metabolic, or digestive conditions, severe kidney failure, unstable diabetes, or uncontrolled high blood pressure.
• People who have used benzodiazepines (a type of sedative or anti-anxiety medication) or barbiturates within the week before the screening visit.
• People who are taking medications that suppress the immune system.
• People with a diagnosis of bipolar disorder, a psychotic disorder, or any other psychiatric condition — past or present — that the trial doctor considers would interfere with the study.
• People with a history of alcohol or drug dependency as defined by standard diagnostic criteria within the past 5 years.
• People with any other medical condition that the trial doctor considers would make participation unsuitable.
• People whose thyroid hormone therapy was started, stopped, or changed within the 3 months before the screening visit.
• People whose menopausal hormone replacement therapy was started, stopped, or changed within the 3 months before the screening visit.
• People currently using certain prohibited medications, including anti-cancer drugs, immunosuppressive drugs, corticosteroids, live vaccines, benzodiazepines, or certain other oral or topical compounds (confirm specific medications with trial site).

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