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:

• People who have been diagnosed with probable Alzheimer's disease based on recognised medical guidelines.
• People aged between 50 and 86 years, male or female.
• People whose memory and thinking test score (called MMSE) falls between 16 and 26 out of 30.
• People whose blood test results show healthy enough levels of protein (albumin), white blood cells, platelets, and red blood cells (confirm with trial site for exact values).
• People whose blood clotting level (INR) is below 1.4.
• People already taking certain memory medications (such as rivastigmine, galantamine, donepezil, or memantine) who have been on a stable dose for at least 4 weeks before the study begins and can remain on that same dose throughout.
• People who speak English.
• People who have completed at least 8 years of formal schooling.
• People whose other long-term health conditions have been managed on a stable medication routine for at least 30 days before the study begins.
• People who have a family member or caregiver who is consistently available, able to help give the study drug (IL-2), and able to attend study visits throughout the trial.
• For people with Alzheimer's disease who have limited ability to make decisions, a legally authorised representative must be present and able to give consent on the person's behalf.

Who may not be able to join:

• People who have an untreated bacterial, fungal, or viral infection.
• People whose kidneys are not functioning well enough, based on a blood test result.
• People whose liver is not functioning well enough, based on certain blood test results.
• People with significant lung problems, such as a history of chronic lung disease that limits their physical activity, or poor lung function test results.
• People with significant heart problems, including uncontrolled irregular heartbeat, a history of fluid around the heart, unstable chest pain, or a heart attack within the past 3 months, or poor heart pumping function on an ultrasound scan.
• People who have had an allergic reaction or known sensitivity to IL-2 (the study drug).
• People with a history of severe stomach or bowel disease.
• People who were hospitalised or had a change in their regular medications within one month before the study begins.
• People whose previous brain scans (CT or MRI) showed bleeding, strokes, more than 3 small areas of damage, brain injury, aneurysm, abnormal blood vessels, fluid build-up, or tumours (with the exception of small, harmless growths called meningiomas).
• People whose test results suggest another type of dementia (such as Lewy body dementia or frontotemporal dementia), another brain or nerve condition (such as Parkinson's disease), a seizure disorder, or infections or nutritional deficiencies affecting the brain.
• People with abnormal thyroid hormone levels on blood tests.
• People with serious or unstable health conditions that could affect the study results, including breathing problems, a heart rate that is too slow or too fast, poorly controlled blood pressure, or poorly controlled diabetes (based on a blood test called HbA1c being above 8%).
• People with a history of cancer within the past 3 years, except for certain fully removed skin cancers or stable, non-spreading prostate cancer for at least 6 months.
• People with a history of hepatitis B or C, or those who carry the hepatitis B virus.
• People who have received an organ transplant.
• People currently being treated with insulin or certain other diabetes medications that stimulate insulin release (such as sulfonylureas or meglitinides).
• People who have taken GLP-1 medications or natural GLP-1 supplements within the past 6 months.
• People with a disability that would prevent them from completing all parts of the study, such as significant vision or hearing loss or severe difficulty with language.
• People currently taking, or planning to take during the study, certain medications including most antipsychotics (above specific low doses), most anti-seizure drugs, certain blood pressure drugs acting on the brain, opioid painkillers, steroid tablets, stimulant medications, most Parkinson's medications, mood stabilisers such as valproate or lithium, or sedatives and anti-anxiety medications (with a limited exception for short-acting sleep aids, which must be avoided for 8 hours before cognitive testing).
• People taking cognitive-enhancing ("nootropic") drugs other than the approved Alzheimer's medications mentioned in the inclusion criteria.
• People taking certain medications that are processed by the liver in a precise way and have a narrow safe dosing range, including warfarin, certain transplant drugs, or theophylline.
• People suspected of, or known to have, a problem with drug or alcohol misuse, including regularly drinking more than approximately one litre of beer or half a litre of wine per day, as indicated by certain blood test results.
• People with a known or suspected allergy to any component of the study treatments.
• People who have taken part in another drug trial within the past 30 days, or within 5 half-lives of that trial drug, whichever is the longer period.
• People for whom a lumbar puncture (spinal fluid sample) would not be safe, for example due to an inability to hold the required position, blood clotting problems, low platelet count, skin infection at the puncture site, use of blood-thinning medication within 90 days (low-dose aspirin is allowed), or certain spinal or brain conditions (confirm with trial site for full details).
• People whom the trial doctor considers unsuitable for any other reason.

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