Phase 1 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 Alzheimer's disease using a specific set of medical standards called the IWG2 criteria, supported by biological test results
• People aged 50 to 85 years old
• People who are enrolled in a social insurance or health coverage scheme
• People with mild Alzheimer's disease that has little or no effect on their ability to manage daily life, as measured by a memory test score of 20 or above
• People whose brain scan shows little or no evidence of white matter changes (a rating called Fazekas score of 1 or less)
• People who have a family member or someone living with them who can watch for any unwanted side effects
• People with a sufficient understanding of French to complete memory and thinking tests
• People who have had a full thinking and memory assessment within the past 6 months
• People taking medication for Alzheimer's disease (anticholinesterase treatment), provided that dose has been stable for at least three months
• People who have given their signed, voluntary, and informed agreement to take part, along with their nominated support person

Who may not be able to join:

• People who have previously been treated with anti-TNF alpha medications (such as etanercept)
• People whose memory or thinking problems are caused by something other than Alzheimer's disease
• People already taking part in another medication study
• People for whom an MRI scan is not safe (for example, those with a pacemaker, an implanted stimulator, or metal fragments near the eye)
• People for whom a lumbar puncture (spinal tap) is not safe
• People with a history of bleeding disorders
• People with severe long-term lung disease
• People currently taking blood-thinning (anticoagulant) medication
• People with certain heart or lung circulation problems, including a right-to-left shunt or severe pulmonary arterial hypertension
• People with known blood vessel disease affecting the brain, significant white matter changes on brain scan (Fazekas score greater than 1), or the after-effects of a stroke
• People currently taking the medications Anakinra, abatacept, or sulfasalazine
• People who have had major surgery within 28 days before the start of the study
• People with a known allergy to gadolinium (a contrast dye used in MRI scans) or any other contrast product used in brain imaging, or people with severely reduced kidney function (glomerular filtration rate below 30 ml/min/1.73m²)
• People with a known allergy to xylocaine (a local anaesthetic)
• People with epilepsy or who are taking medications that may lower the threshold for seizures (confirm with trial site for the specific list)
• People with severe depression that has not responded to appropriate treatment, and/or people experiencing psychotic symptoms
• People whose MRI scan shows signs of an active brain condition such as infection, tumour, or large bleed
• Women who have not yet reached menopause
• People who are under a legal protection arrangement other than guardianship or curatorship (confirm with trial site)
• People with a history of inflammation of the optic nerve (optic neuritis)
• People with signs or symptoms consistent with multiple sclerosis
• People who have received certain live vaccines (yellow fever or BCG) within 4 weeks before starting the study treatment
• People with a history of hepatitis B or C
• People who have recently had a heart attack or have unstable heart disease
• People with a history of repeated or ongoing infections, or conditions such as severe or poorly controlled diabetes that increase infection risk
• People with a known sensitivity or allergic reaction to etanercept or any ingredient in the medication Benepali
• People with active infection, including long-term or localised infections, or a high risk of serious infection (sepsis)
• People with uncontrolled high blood pressure
• People with respiratory distress syndrome
• People with heart or circulation instability (confirm with trial site for specific details)
• People with a known sensitivity or allergic reaction to SonoVue (an ultrasound contrast agent)

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