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:

• Both the person with Alzheimer's and a trusted caregiver or support person must be willing to sign a consent form agreeing to take part and follow the trial rules.
• A reliable caregiver or support person must be available who spends at least 10 hours per week with the participant, can attend trial visits, help with medication, and complete caregiver questionnaires.
• People aged 50 to 85 years at the time of giving consent.
• Female participants must have gone through menopause at least 2 years ago, or have had a surgical procedure that means they cannot become pregnant, at least 6 months before the screening visit.
• Male participants whose partners could become pregnant must agree to use reliable contraception during the trial and for 6 months after finishing the trial treatment.
• People who have been clinically diagnosed with mild to moderate Alzheimer's disease (Stages 4–5 under the NIA-AA 2018 criteria) at the time of screening.
• People who have supporting test results confirming Alzheimer's disease — either from a spinal fluid (CSF) test within the last 3 years, a positive amyloid PET brain scan within the last 3 years, or a blood test (plasma pTau217 at a level of 2.0 pg/mL or above).
• People who have shown signs of worsening memory or thinking over the past year, based on caregiver observations, medical records, or cognitive testing.
• People who have had a brain scan (MRI or CT) within the past 12 months showing findings consistent with mild to moderate Alzheimer's disease and no other significant brain conditions, especially stroke-related changes (or who can have one completed before starting treatment).
• People who score between 18 and 26 on the Mini-Mental State Examination (MMSE), a standard cognitive test, at screening.
• People who score 4 or below on the Modified Hachinski Ischemic Scale (a test to check if memory problems may be related to blood vessel issues), unless a recent MRI rules out vascular causes.
• People who are already taking an Alzheimer's medication called an AChEI (such as donepezil, galantamine, or rivastigmine) at a stable dose for at least 3 months before the baseline visit.
• People with adequate vision, hearing, and physical ability to complete the study tests.
• People who are able to swallow a size 2 capsule.
• People who are in reasonably good health, in the investigator's opinion, to participate in a 21-week trial.
• People who agree to have their ApoE gene (a gene linked to Alzheimer's risk) tested as part of the trial.

Who may not be able to join:

• People who are unable to attend scheduled visits or complete required assessments.
• People who are currently taking, have taken within the past 4 weeks, or plan to start taking memantine (an Alzheimer's medication), unless they have been on a stable dose for at least 8 weeks before screening.
• People who have previously received anti-amyloid immunotherapy treatments (such as aducanumab, lecanemab, or donanemab) or an anti-amyloid vaccine.
• People who have taken part in another clinical trial or received an experimental drug within the past 3 months, or who have previously taken part in trials involving certain antibody-based treatments targeting amyloid.
• People who have used anticholinergic medicines (including a bladder medicine called trospium) within the 2 weeks before screening.
• People currently taking certain medications that may affect the trial, including: long-acting benzodiazepines (e.g., diazepam/Valium); some shorter-acting benzodiazepines unless taken at a stable dose for sleep for at least 4 weeks; sedating antihistamines taken within 12 hours of cognitive testing; certain anti-seizure medications that significantly affect thinking; certain antidepressants that may affect cognition (unless on a stable dose for at least 4 weeks); regularly used antipsychotic medications above low doses; medications used to treat Parkinson's disease (such as levodopa, amantadine, selegiline, or MAO inhibitors for Parkinsonism); prescription opioid/narcotic pain medications taken within 4 weeks before screening; medications known to affect heart rhythm (QT interval), unless on a stable dose for at least 12 weeks with a demonstrated stable heart rhythm; any recreational or illegal drugs including cannabis; and certain blood pressure medications that act on the brain (such as clonidine or methyldopa).
• People who have been hospitalised or had a significant change to their regular medications within 4 weeks before or during screening.
• People whose test results or brain scans suggest another type of dementia or brain condition, such as Lewy body dementia, frontotemporal dementia, Parkinson's disease, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, significant stroke-related brain changes, brain tumours, seizure disorders (except childhood febrile seizures), or other infections or conditions affecting the brain.
• People who have been diagnosed with severe active depression, schizophrenia, or bipolar disorder, or who are considered at risk of suicide — including a suicide attempt in the past 12 months or certain types of suicidal thoughts within 60 days of screening.
• People with a history of substance abuse in the past 12 months, a positive drug or alcohol test at screening, or any use of cannabis (including prescribed cannabis).
• People with significant active or chronic infections at screening, including HIV, active hepatitis B, or hepatitis C.
• People with serious or unstable medical conditions that could interfere with the trial, including: significant breathing problems; heart attack, unstable chest pain, heart failure, or serious heart muscle disease within the past 6 months; an abnormally slow or fast heart rate; certain heart rhythm problems or a prolonged QT interval on an ECG; poorly controlled high or low blood pressure.
• People with significantly reduced kidney function at screening (creatinine clearance of 60 mL/min or below, confirmed by repeat testing).
• People with poorly controlled diabetes, indicated by an HbA1c (a blood sugar measure) above 8.5% at screening.
• People with chronic liver disease or significantly abnormal liver function test results at screening.
• People with a history of cancer, with some possible exceptions (such as cancers in remission for 5 or more years, treated skin cancers, or completed prostate cancer treatment at least 6 months before screening — to be decided in discussion with the trial sponsor).
• People with a known allergy to any of the trial medications or their ingredients.
• People who the investigator considers unsuitable for the trial for any reason.
• People who are in any way dependent on the trial sponsor or investigator, or who are living in a facility under a court or administrative order.
• Female participants who are pregnant, breastfeeding, or planning to become pregnant.
• Male participants whose partner is pregnant, breastfeeding, or planning to become pregnant.
• People who need a brain MRI but cannot have one due to medical implants (such as certain pacemakers or metal implants) or severe claustrophobia that cannot be managed medically.
• People who have a medical reason they cannot take the study drug trospium chloride, including known allergy to trospium or its ingredients, myasthenia gravis (a muscle weakness condition), urinary retention, stomach or bowel blockage, certain bowel conditions, or uncontrolled narrow-angle glaucoma.

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