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 who have been diagnosed with probable Alzheimer's disease (mild, moderate, or severe) based on recognised medical guidelines, with a memory test score between 0 and 24 out of 30.
• People whose Alzheimer's diagnosis has been confirmed through blood or brain scan tests showing specific protein markers (amyloid and tau) associated with the disease.
• People aged 50 to 90 years (inclusive), of any gender, who have completed at least primary school education.
• People who are either not taking any Alzheimer's medications, or who have been on a stable dose of approved Alzheimer's treatments for at least 12 weeks before the study starts; other regular medications must also have been stable for at least 4 weeks beforehand.
• People whose brain scan results and other assessments suggest their condition is likely due to Alzheimer's disease rather than other causes (confirm with trial site).
• People whose depression screening score is 4 or below on a standard 15-question scale.
• People whose brain scan (CT or MRI) shows age-related changes or some shrinkage of brain tissue.
• People who have a reliable and consistent caregiver, as confirmed by the trial doctors.
• People who are able to provide written consent themselves, or whose legally authorised representative can do so on their behalf; participants must also agree to provide blood, stool, and urine samples during the study.

Who may not be able to join:

• People diagnosed with a type of dementia other than Alzheimer's disease, or with another brain or nervous system condition.
• People with unstable vital signs or significant problems affecting the heart, lungs, liver, kidneys, or other organs.
• People with very low folate or vitamin B12 levels, an underactive thyroid that may have caused or worsened their dementia, or a positive syphilis test result.
• People who have a diagnosed psychiatric condition alongside their Alzheimer's disease.
• People with a long history of heavy alcohol use or substance abuse that could affect how the treatment is assessed.
• People who are known to be intolerant or allergic to the study medications.
• People whose brain MRI shows significant abnormalities such as strokes, bleeding in the brain, fluid build-up, or brain tumours.
• People who have had, or currently have, a significant heart or blood vessel condition requiring treatment within the past 12 months.
• People who have used 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 antibiotics during the study.
• People whose depression screening score is higher than 4 on the standard 15-question scale.
• People with any other poorly controlled health condition — such as heart, breathing, kidney, or digestive problems (including stomach cancer, gastric bypass surgery, or ongoing diarrhoea) — that could affect their safety or the study results, as judged by the trial doctors.
• People who have taken part in a clinical trial of a new Alzheimer's drug within the past 6 months, unless it has been confirmed they received only a placebo (inactive treatment).
• People with significant abnormalities found during physical checks, vital signs, blood tests, or heart trace (ECG) that need further investigation or treatment.
• People who have participated in a clinical trial involving certain immune-based treatments (such as therapeutic antibodies, immunoglobulin therapy, or vaccines) within the past 6 months, unless confirmed to have received only a placebo.
• People who have ever taken part in a clinical trial involving anti-amyloid treatments (such as certain antibody therapies or BACE inhibitors), unless confirmed to have received only a placebo.
• People with uncontrolled immune disorders requiring ongoing treatment with certain immune-suppressing or immune-modifying therapies during the study period.
• People with uncontrolled bleeding disorders, a very low platelet count, or certain abnormal blood clotting results; people on blood-thinning medications must have been on a stable, optimised dose for at least 4 weeks before the study starts, and those on blood thinners will not be able to take part in any spinal fluid testing.

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