Phase 3 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 diagnosed with Alzheimer's disease (AD) based on recognised medical criteria, both men and women (women must not be able to become pregnant)
• People aged between 50 and 85 years
• People who have had a brain scan (MRI or CT) that supports the Alzheimer's diagnosis and rules out other causes of memory problems
• People who have either had a spinal fluid test (lumbar puncture) showing results that support an Alzheimer's diagnosis, or a brain scan that detected amyloid protein buildup
• People who have been using a rivastigmine skin patch for at least 3 months, with the last month at the 9.5mg/day dose (or for at least 1 month at that dose if donepezil was used before switching to rivastigmine)
• People with mild to moderate Alzheimer's, based on a specific memory and thinking test score between 18 and 26 (MMSE)
• People rated as having mild cognitive decline on a standard dementia rating scale (CDR score of 0.5 or 1)
• People who show signs of reduced function in the front part of the brain, based on a specific test score of 14 or below (FAB)
• People who do not have significant depression, based on a standard mood questionnaire score below 5 (GDS)
• People who have had at least 5 years of formal schooling
• People whose medical records show a documented decline in memory or thinking lasting more than 6 months
• People who have a caregiver living with them or regularly available to help with medication if needed
• People living at home or in a care facility that does not provide round-the-clock nursing care
• People whose general health is considered suitable for taking part in a 6-month clinical trial
• People whose treatment for any other ongoing health condition has been stable for at least 1 month before the screening visit
• People who are not regularly taking any medications listed as prohibited in the trial
• People (and their caregiver) who have signed a consent form agreeing to take part; if there is any question about a person's ability to consent, an independent doctor must confirm they are capable before any trial activities begin

Who may not be able to join:

• People who are unable to complete the required screening or baseline assessments
• People who were hospitalised or had a change in their regular medications within one month before or during the screening period
• People whose test results, brain scans, or clinical findings suggest another type of dementia (such as Lewy body dementia, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, or Down's syndrome)
• People with another brain or nervous system condition (such as Parkinson's disease, motor neurone disease, a history of severe head injury, brain tumour, or blood clot around the brain)
• People with blood pressure that drops significantly when standing up, or other problems with the body's automatic functions
• People with significant damage to the brain's blood supply (such as a major stroke, multiple small strokes, or extensive changes to the brain's white matter)
• People with a history of epilepsy or seizures
• People with infections or conditions affecting the brain or nervous system (such as syphilis, untreated underactive thyroid, or low vitamin B12 or folate levels)
• People currently diagnosed with major depression, schizophrenia, or bipolar disorder (as defined by current psychiatric diagnostic standards)
• People who have had any thoughts or actions related to suicide (based on a specific assessment tool)
• People with a history of any kind of psychosis
• People with significant liver disease or abnormal liver test results above a defined threshold
• People with breathing difficulties or respiratory insufficiency
• People with significant kidney problems (above a defined threshold), unless a follow-up kidney test shows normal results
• People who have had a heart attack, unstable chest pain, heart failure, or a heart muscle condition within the 6 months before screening
• People with a heart rate below 50 beats per minute or above 95 beats per minute
• People with high blood pressure (above 140/90 mmHg) or low blood pressure (below 90/60 mmHg) that requires more than three medications to manage
• People with certain heart rhythm problems, including specific types of heart block, long QT syndrome, or a prolonged QT interval on a heart tracing (above defined thresholds for men and women)
• People with poorly controlled diabetes (HbA1c above 8.5)
• People who have had a cancer diagnosis within the past 5 years (except certain skin cancers or slow-growing prostate cancer)
• People with cancer that has spread to other parts of the body
• People with a disability that would prevent them from completing all study tasks (such as severe vision loss, hearing loss, or significant difficulty communicating)
• Women who are able to become pregnant
• People taking certain medications daily for 14 days or more (or expected to), including: benzodiazepines, antipsychotics, strong sedatives, anti-epileptic drugs, certain blood pressure medications that act on the brain, opioid-based pain relief, or certain brain-stimulating drugs (except Ginkgo Biloba)
• People with suspected or confirmed drug or alcohol misuse (more than approximately 60g of alcohol per day, equivalent to about 1 litre of beer or 500ml of wine)
• People with a known or suspected allergy to any component of the study treatments, including rotigotine or any ingredient in the patches
• People who have taken part in another clinical trial or received an experimental drug within the previous 3 months (or longer, depending on how long the drug stays in the body)
• People considered unsuitable for inclusion for any other reason, based on the trial investigator's judgement
• People who are in any way dependent on the trial sponsor or lead investigator, or who are living in a facility under a court or government order

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