Phase 2 Alzheimer's Disease Trial, Not Yet 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, with the diagnosis confirmed using an approved test that detects Alzheimer's-related changes in the brain.
• People who have already received the Alzheimer's treatment lecanemab (brand name Leqembi®) at the standard dose, and have completed at least 14 infusions before the screening visit.
• People aged 60 to 85 years at the time of signing the consent form.
• People with a body mass index (a measure of body weight relative to height) between 18 and 35.
• People who scored between 16 and 24 on a standard memory and thinking test called the MMSE at the screening visit (this range reflects mild-to-moderate memory difficulties).
• People who had a brain MRI scan done before their 14th lecanemab infusion.
• People who have had a stable living situation for at least 6 weeks before the screening visit — including those living at home, in a nursing home, assisted living, or memory care facility.
• People who can communicate verbally well enough to take part in study procedures (hearing aids and reading glasses are permitted, and wheelchair users are welcome to participate).
• People who, before their memory difficulties began, had enough reading and number skills to complete the thinking and memory tests used in the study.
• People who are currently taking approved Alzheimer's symptom medications (such as donepezil, rivastigmine, galantamine, or memantine) may be eligible, provided the dose has been stable for at least 12 weeks before screening and remains stable throughout the study.
• People who use medical cannabis or marijuana may be eligible if there is a valid prescription or documented medical recommendation on file, use has been stable for at least 4 weeks before the baseline visit, and it is not used within 12 hours before thinking or memory assessments.
• People who are not pregnant, not breastfeeding, and not within 3 months of giving birth may be eligible (additional conditions apply for people who could become pregnant — confirm with trial site).
• People who carry a genetic variant called ApoE e4 may be eligible, provided they do not carry two copies of this variant (confirm with trial site).
• People taking blood-thinning medications (anticoagulants) may be eligible if the dose has been stable for at least 4 weeks before screening and there is no recent history of stroke or other relevant neurological conditions (confirm with trial site).
• Each participant must have an identified caregiver or study partner who spends approximately 10 or more hours per week in direct contact with them, is willing to attend all study visits, can accurately report on the participant's thinking and daily functioning, and agrees to provide written consent to take part in the study.

Who may not be able to join:

• People assessed as being at risk of suicidal behaviour, including those who have reported certain types of suicidal thoughts in the past 2 months or suicidal behaviours in the past 12 months.
• People with a current major psychiatric diagnosis (such as major depression, bipolar disorder, or schizoaffective disorder) or severe psychiatric symptoms (such as hallucinations, severe agitation, or delusions) that could affect the study results or the person's ability to complete the study.
• People with a history of schizophrenia or other long-term psychotic conditions.
• People with any ongoing or uncontrolled psychiatric condition that could interfere with study assessments.
• People with serious or unstable medical conditions affecting the heart, lungs, kidneys, blood, digestive system, hormone system, immune system, skin, nervous system, or cancer, if these are considered likely to affect safety or study results.
• People who have had an ischemic stroke (a stroke caused by a blocked blood vessel) in the 12 months before screening, or any history of a bleeding stroke.
• People with a history of cerebral amyloid angiopathy (a condition involving protein deposits in brain blood vessels), epilepsy, brain tumours, or unstable thyroid function.
• People with a history of, or high risk of, difficulty emptying the bladder, stomach emptying problems, or a type of eye pressure condition called narrow-angle glaucoma.
• People with active gallbladder or bile duct problems (such as symptomatic gallstones or inflammation).
• People with a history of bladder stones, repeated urinary tract infections, or — for male participants — certain prostate-related measurements above defined thresholds at screening (confirm with trial site).
• People with any level of liver impairment.
• People with HIV with detectable levels of the virus, hepatitis C, liver cirrhosis, bile duct abnormalities, liver or bile duct cancer, or active liver viral infections.
• People with a history of irritable bowel syndrome or serious constipation requiring treatment in the past 6 months.
• People with a known allergy or sensitivity to any ingredient in the study medication.
• People with certain heart conditions, including moderate-to-severe heart failure, significant angina (chest pain), serious heart rhythm problems, a history of a heart attack in the past 6 months, or a personal or family history of a condition called long QT syndrome.
• People who have had a significant infection or illness in the 2 weeks before screening (rescreening may be possible after recovery — confirm with trial site).
• People who are currently taking part in another clinical trial involving an experimental treatment, or have done so in the past 4 weeks, or who have participated in more than 2 clinical trials in the past 12 months.
• People with significant abnormal findings on physical examination, heart tracing (ECG), or blood and urine tests at screening.
• People with significant abnormal findings on the brain MRI taken before their 14th lecanemab infusion, including certain types of bleeding, brain lesions, or other structural concerns (confirm with trial site for specific details).
• People with a history of unexplained fainting, dizziness on standing, or a nervous system condition affecting automatic body functions; or those found to have symptomatic low blood pressure on standing at screening.
• People with a history of a significantly slow heart rate, or a heart rate below 50 beats per minute at screening.
• People who are pregnant, breastfeeding, or within 3 months of giving birth.
• People who have previously been exposed to the specific study drug being tested in this trial (referred to as X/T in the eligibility criteria — confirm with trial site).
• People who are currently taking, or have taken within the past 6 months, any other disease-modifying anti-amyloid treatment for Alzheimer's disease, other than Leqembi®.
• People who are unable to stop taking a medication that is not permitted in this study (such as strong anticholinergic or antihistamine medications).
• People who have taken certain types of medications in the past 3 months, including monoamine oxidase inhibitors, some anti-seizure medications, mood stabilisers (such as lithium), or tricyclic antidepressants — with some exceptions (confirm with trial site).
• People with reduced kidney function, specifically an eGFR (a measure of how well the kidneys are filtering blood) below 50 mL/min.
• People with significantly elevated liver enzyme levels or bilirubin in blood tests at screening (with a possible exception for a specific genetic condition called Gilbert's syndrome — confirm with trial site).
• People with unstable high blood pressure (at or above 150/100 mmHg) or a fast heart rate (at or above 100 beats per minute) at screening.
• People whose urine test at screening is positive for certain substances including PCP, amphetamines, opiates, cocaine, or significant alcohol use.
• People with a heart tracing (ECG) showing a prolonged QT interval above defined thresholds at screening.
• People with vitamin B12 levels below the normal range.
• People who are in prison or involuntarily detained (with very limited exceptions in certain countries — confirm with trial site).
• People who cannot have a brain MRI, such as those with a cardiac pacemaker, defibrillator, or certain metal implants in the body.
• People with a moderate-to-severe alcohol or substance use disorder in the past 2 years.
• People who carry two copies of the ApoE e4 genetic variant.
• People considered unsuitable for the trial by the study doctor or medical monitor for any other safety or practical reason.

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