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 aged 65 to 80 years old at the time of signing consent forms
• People with a mild to moderate level of memory and thinking problems, based on specific standard memory tests (scores within defined ranges on the CDR, MMSE, and Logical Memory II tests)
• People whose blood or other test results show signs of Alzheimer's disease (a specific protein called pTau 217, or an amyloid test done within the past 2 years)
• People who took part in a previous trial testing an anti-amyloid antibody treatment, where the final brain scan from that trial showed no signs of a side effect called ARIA (a type of brain swelling or bleeding)
• People with medical records confirming that Alzheimer's symptoms began at age 60 or later
• People with no active depression and a low score on a standard depression checklist (Geriatric Depression Score below 6)
• People whose dose of Alzheimer's medications (such as acetylcholinesterase inhibitors or memantine) has not changed in the past six months, and where no change is expected during the study
• People living at home with a reliable caregiver who sees them at least 3 times per week for 10 or more hours, and who is able to help manage the study medication
• People (and their caregivers) who are willing and able to sign written consent forms
• People whose body weight is between 55 and 110 kg and whose body mass index (BMI) is between 18 and 35 (confirm with trial site)
• Men who agree not to donate sperm during the treatment period and for at least 90 days after the last dose, and who either remain abstinent from sexual intercourse, or use a condom consistently during any sexual activity where ejaculation could occur
• Women who are no longer able to become pregnant — either because it has been at least two years since their last period, or because they have had surgery that prevents pregnancy

Who may not be able to join:

• People with a significant current or past history of serious heart, lung, liver, kidney, digestive, hormonal, blood, or neurological conditions that could affect how the body processes medication, pose a risk during the study, or make results difficult to interpret (people with stable, well-managed conditions may still be considered by the trial team)
• People whose score on the MMSE memory test changes by more than 2 points between the screening visit and the starting visit, or where different thinking tests give conflicting results about the severity of the condition
• People who have been diagnosed with a brain or memory condition other than Alzheimer's disease — such as Parkinson's disease, Huntington's disease, frontotemporal dementia, multi-infarct dementia, Lewy body dementia, or normal pressure hydrocephalus
• People who are unable to tolerate a lumbar puncture (spinal tap) procedure to collect spinal fluid
• People taking blood-thinning medications that would make a lumbar puncture unsafe
• People for whom an MRI scan is not safe or suitable (for example, due to a pacemaker or metal implants — confirm with trial site)
• People with a significant structural brain problem identified in their medical history or records, such as strokes, blood clots, bleeding, fluid build-up, brain tumours, or severe damage to small blood vessels in the brain
• People whose MRI results suggest their memory or thinking problems may be caused by something other than Alzheimer's disease
• People with a history of a brain injury (such as a concussion) or brain infections (such as HIV or syphilis) that are still affecting their thinking ability
• People with a history of seizures or epilepsy — with exceptions for childhood fever-related seizures or seizures caused by a resolved medical problem, where the person has been seizure-free without medication for at least 2 years
• People with autoimmune conditions, active infections, or other conditions affecting the immune system, or those currently taking immune-suppressing medications
• People with a current or long-term history of significant liver disease, including hepatitis, alcohol-related liver disease, or other named liver conditions
• People with significant liver or bile duct problems (other than a harmless condition called Gilbert's syndrome, or gallstones causing no symptoms)
• People with abnormal thyroid hormone levels at the start of the study; people with a known thyroid condition must have been stable on treatment for 6 months before joining, with no dose changes expected during the study
• People living in a nursing home or care facility who require continuous direct medical care and nursing supervision (those in such facilities who do not need continuous direct care may still be considered)
• People who require close or constant help with personal care or basic daily tasks
• People with a history of psychiatric conditions such as schizophrenia or bipolar disorder
• People with any current or historical indication of suicide risk, based on personal history, family reports, or medical records
• People taking medications that have strong interactions with the study drug, where those medications cannot be safely stopped for a required period before and during the study
• People who have received a biological therapy (such as an antibody-based drug) within the 3 months before the study starts, or within 5 half-lives of that drug (confirm with trial site)
• People currently enrolled in, or who have taken part in, another clinical trial involving an experimental treatment within the past 30 days before signing consent
• People with abnormal blood test results considered significant by the trial doctor, including: liver enzyme levels (ALT or AST) more than 1.5 times the upper normal limit; bilirubin levels more than 1.5 times the upper normal limit; a heart rhythm measurement (QTcF) above 450 ms for men or 470 ms for women; or a positive test for drugs or alcohol
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People who have regularly used illicit drugs within the past 3 years
• People who are unable to avoid taking certain brain-acting medications (such as benzodiazepines or stimulants) for the required time before cognitive testing and brain activity (EEG) assessments
• People for whom routine blood draws for study purposes are not possible
• People who test positive for SARS-CoV-2 (COVID-19), hepatitis B, hepatitis C, HIV, or syphilis

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