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:

• The person joining the trial, or their legal representative, must be willing and able to give written consent and follow the study's requirements.
• A reliable care partner (such as a family member or partner — always the same person) must be available, able to speak the language used in assessments, willing to help with certain study evaluations, and willing to sign their own consent form.
• People who have been diagnosed with Alzheimer's dementia according to the 2011 National Institute on Aging–Alzheimer's Association diagnostic guidelines.
• People aged between 40 and 85 years old.
• People who have completed at least 6 years of formal schooling and are fluent in the language used for testing.
• Women who could become pregnant must have a negative pregnancy test before starting the study drug, and all participants who could father or carry a child must agree to use an acceptable form of contraception during the study and for 30 days after the last dose (acceptable options include condoms, diaphragms, IUDs, hormonal birth control used for at least 30 days beforehand, or a vasectomised partner).
• People who have had a brain scan (called an amyloid PET scan) within the past six months that shows positive evidence of Alzheimer's-related amyloid in the brain.
• People whose Alzheimer's severity falls within a specific range on a standard assessment scale called the CDR-SB, with a score of 9.5 or above but below 16.0 (confirm with trial site).

Who may not be able to join:

• People with a significant level of blood vessel damage in the brain, defined as Fazekas Grade 3 (confirm with trial site).
• People who have had a stroke or bleeding in the brain that the study doctor believes contributed to their memory or thinking problems.
• People with a history of substance use disorder that has not been in remission for at least 12 months.
• People who have had cancer (other than a type of skin cancer called basal cell carcinoma) or received cancer treatment within the past 5 years.
• People with uncontrolled heart or circulation problems, such as uncontrolled heart failure, fast or irregular heartbeat, or uncontrolled high blood pressure.
• People who have had a stroke, a mini-stroke (TIA), or an unexplained loss of consciousness within the past year.
• People with a serious lung condition that causes low oxygen levels in the blood.
• People with significant heart disease, a heart attack within the past two years, ongoing chest pain, breathing difficulties when lying down, certain heart rhythm problems, or heart disease classified as a serious level (NYHA class III or IV).
• People with significant liver disease, such as cirrhosis, active hepatitis B or C, or liver tumours.
• People whose liver function blood tests show results more than three times the upper limit of normal during screening.
• People with significant digestive system problems, such as gastrointestinal bleeding in the past two years, difficulty absorbing nutrients, previous stomach removal surgery, or active stomach ulcers.
• People with immune system disorders that the study doctor considers clinically significant, such as lupus or scleroderma.
• People with uncontrolled or unstable blood disorders, such as severe anaemia or bone marrow suppression.
• People with other neurological conditions (such as Lewy body dementia, Parkinson's disease, Huntington's disease, epilepsy, multiple sclerosis, or stroke) or psychiatric conditions (such as schizophrenia or intellectual disability) that affect thinking and cognition.
• People with unstable or uncontrolled major depression or anxiety within the past 12 months.
• People who have had a seizure in the past three years.
• People with uncontrolled hormonal or gland-related conditions, such as uncontrolled diabetes or overactive thyroid, in the study doctor's judgement.
• People with severely reduced kidney function, defined as a GFR below 30 mL/min/1.73 m² on screening blood tests.
• People with HIV, hepatitis B, hepatitis C, or any other active infection or systemic disease.
• People currently taking blood-thinning medications (anticoagulants), except for low-dose aspirin at or below a preventive dose.
• People taking Alzheimer's medications such as memantine or acetylcholinesterase inhibitors at doses above the recommended range, or who have not been on a stable dose for at least 30 days before enrolling.
• People for whom an MRI or amyloid PET scan of the brain cannot be safely performed.
• People whose safety the study doctor believes would be put at risk by taking part in this trial.
• People with any medically unstable or uncontrolled health conditions not otherwise listed.
• People who have made a suicide attempt or shown suicidal behaviour in the past 2 years.
• People who have experienced certain levels of active suicidal thoughts (type 4 or 5 on a standard scale called the C-SSRS) in the past 3 months.

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