Phase 3 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 aged between 50 and 85 years old (inclusive)
• People who have had at least 4 years of formal schooling and are able to complete memory and thinking tests as required by the trial
• People who have had a documented, gradually worsening memory decline for at least 12 months before screening
• People who have been diagnosed with mild to moderate Alzheimer's disease dementia according to recognised medical guidelines
• People who have evidence of a specific Alzheimer's-related protein (amyloid) in the brain, confirmed by either a brain scan (amyloid PET) or a spinal fluid test — past results may be accepted
• People whose score on a standard memory and thinking test (MMSE) falls within a specified range (15–26, or 12–22 for those with only primary school education)
• People whose score on a standard dementia severity rating falls within a specified range (CDR Global score of 1 or 2, with a memory sub-score of at least 0.5)
• People already taking certain Alzheimer's medications (acetylcholinesterase inhibitors or memantine) who have been on a stable dose for at least 12 weeks before the start of the trial
• People who have at least one reliable support person (such as a family member or close friend) who knows them well, can accompany them to treatment sessions, can report on their thinking and behaviour, and is able to communicate with trial staff by phone or messaging app and attend required visits
• People (or their legal representative) who are willing to participate and provide written consent before any trial procedures begin

Who may not be able to join:

• People whose memory or thinking problems are caused by something other than Alzheimer's disease, such as vascular dementia, brain infections, Parkinson's disease, Lewy body dementia, brain injury, toxic exposure, organ-related brain conditions, brain tumours, or hormone or vitamin deficiencies
• People whose brain MRI shows significant abnormalities, such as multiple or strategically located strokes, extensive white matter damage, or space-occupying growths such as cysts, abscesses, or tumours (very small meningiomas or arachnoid cysts under 1 cm may not necessarily exclude someone — confirm with trial site)
• People who have had a mini-stroke (TIA), stroke, or seizure within the 6 months before screening
• People whose score on a scale measuring stroke-related brain changes (Hachinski Ischemic Score) is above 4
• People whose score on a depression rating scale (HAMD-17) is above 10
• People who have been diagnosed with a psychiatric condition such as schizophrenia, bipolar disorder, major depression, or delirium at the time of screening
• People with a known or confirmed history of HIV infection or neurosyphilis
• People with severe heart disease, including serious heart failure, severe or unstable chest pain (angina), or a heart attack within the past 6 months
• People with severe dysfunction of major organs such as the heart, lungs, liver, or kidneys, or any other medical condition that the trial doctor believes would make participation unsafe or interfere with the study
• People who have previously received or are currently receiving anti-amyloid antibody treatments (such as aducanumab, lecanemab, or donanemab)
• People who have previously had or are planning to have a specific type of lymphatic vessel surgery (lymphaticovenous anastomosis) in the neck area
• People who have taken part in another interventional clinical trial (involving a drug or medical device) within the 30 days before screening (observational studies or confirmed placebo participation may be exceptions — confirm with trial site)
• People who have had a severe head injury, have implanted devices in the skull, or have any reason they cannot undergo an MRI scan (such as claustrophobia, a pacemaker, or certain metal implants), or who are unwilling to have an MRI
• People who have contraindications to PET scanning or an allergy to the PET scan tracers used in this trial (certain exceptions may apply — confirm with trial site)
• People who have had a cancer diagnosis within the past 5 years, with some exceptions for certain treated skin cancers, early-stage cervical cancer, contained and stable prostate cancer, and treated non-recurring breast cancer (confirm with trial site)
• Women who are pregnant, breastfeeding, planning a pregnancy, or of childbearing potential who are not using a highly effective form of contraception
• People who have any other condition that the trial doctor believes could affect their safety, their ability to follow the trial procedures, or the reliability of the study results

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