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:

• A person must meet the medical definition of probable Alzheimer's disease dementia as set out by the National Institute on Aging and Alzheimer's Association (2024 criteria).
• Participants must be male or a female who is past menopause (no longer able to have children), and between 50 and 90 years of age (inclusive), with at least a primary school level of education.
• Cognitive test scores must fall within specific ranges depending on education level — a memory and thinking test (MMSE) score at or below a certain threshold based on schooling, and a dementia severity rating (CDR) score above 2.0, indicating more advanced dementia.
• Scores on a daily living activities scale (ADL) must be greater than 0 and no higher than 40, reflecting some difficulty with everyday tasks.
• A nutritional risk screening score of 3 or higher at the time of enrolment, indicating some level of nutritional risk.
• General physical health must be reasonably stable, with a functional ability score (ECOG) of 3 or lower.
• People currently taking approved Alzheimer's medications must have been on a stable dose for at least 12 weeks before the study starts, with stable cognitive scores; people not yet on any Alzheimer's medication may also be eligible.
• All other regular medications (not related to Alzheimer's) must have been at a stable dose for at least 4 weeks before the study begins.
• A reliable caregiver must be available and confirmed by the trial site.
• Participation must be voluntary, with informed consent signed by the participant or, where the participant cannot consent, by an authorised representative according to local laws; participants must also agree to provide blood, stool, and urine samples during the study.

Who may not be able to join:

• People whose dementia is caused by something other than Alzheimer's disease — such as vascular disease, brain infections, Huntington's disease, Parkinson's disease, Lewy body dementia, brain injury, poisoning, liver or lung disease affecting the brain, brain tumours, thyroid or other hormonal conditions, vitamin deficiencies, or any other non-Alzheimer's cause.
• People with co-existing autoimmune conditions, such as multiple sclerosis, rheumatoid arthritis, lupus, myasthenia gravis, or similar disorders.
• People with severely reduced kidney function, serious liver disease or significantly elevated liver enzymes, a heart attack or major heart procedure within the past 6 months, severe heart failure, or other serious neurological, heart, lung, blood, hormonal, or psychiatric conditions.
• People with a known or suspected history of alcohol or drug misuse.
• People with a life expectancy of 3 months or less.
• Women who are pregnant or breastfeeding, or people of childbearing potential (including male participants whose female partners could become pregnant) who are planning a pregnancy or unwilling to use effective contraception from screening through to 3 months after finishing the study drug.
• People with a known allergy or sensitivity to any ingredient in the study medication.
• People who have taken part in another clinical drug trial within the past 30 days, or who are currently enrolled in another clinical trial.
• People with any other serious physical or mental illness, or abnormal test results, that the trial site determines could make participation unsafe or unsuitable.
• People with clinically significant psychiatric conditions or severe psychiatric symptoms.
• People with an MMSE score above 26 (indicating cognition is too mildly affected for this trial).
• People with an ADL daily living score above 40.
• People with significantly elevated cancer markers, a history of cancer, or tumours of unknown nature.
• People considered to be at significant risk of suicide.
• People with ongoing alcohol or substance misuse that could affect the study's ability to measure outcomes.
• People with a known intolerance or allergy to any of the drugs used in this study.
• People with a significant heart or blood vessel (cardiovascular or cerebrovascular) condition that required treatment within the past 12 months, or a current diagnosis of such a condition.
• People who have taken antibiotics continuously for more than 10 days in the 12 weeks before the study starts, or who are expected to need more than 10 days of antibiotic treatment during the study.
• People with poorly controlled or unstable medical conditions that could affect how the body absorbs medication or interfere with study assessments — such as stomach cancer, gastric bypass surgery, or recurring diarrhoea, among others.
• People with any significant abnormality found during physical examination, vital signs, blood tests, or heart trace (ECG) that the trial site considers may affect safety or interfere with the study.
• People with poorly controlled bleeding disorders, including a platelet count below 50 x 10⁹/L or an INR above 1.5 (in those not taking blood thinners such as warfarin).
• People whom the trial site considers unsuitable for any other reason.

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