Phase 2 Brain Cancer 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 early Alzheimer's disease — specifically, mild cognitive impairment (Stage 3) or mild Alzheimer's dementia (Stage 4), as defined by the FDA in 2018
• People who have had a brain scan (amyloid PET) or specific lab tests (spinal fluid or blood) showing abnormal levels of Alzheimer's-related proteins (amyloid or tau)
• People with a score of 0.5 or 1.0 on a standard memory and thinking assessment called the CDR (Clinical Dementia Rating), and who have had a brain MRI within the past two years with no findings that rule out Alzheimer's disease
• People who, in the judgement of an experienced doctor, are able to understand and agree to take part in the trial
• People who have a reliable contact person (such as a family member or close friend) who sees or speaks with them regularly and can provide input about how they are doing
• People aged 50 years or older
• People who are fluent in Norwegian and show signs of having had adequate intellectual functioning before their diagnosis
• People who are able to attend all scheduled visits and complete all required assessments
• Female participants who are not able to become pregnant, or who have a negative pregnancy blood test within 14 days of the start of the study and agree to use effective contraception throughout the trial

Who may not be able to join:

• People with significant blood vessel disease in the brain, shown by their medical history, a neurological examination, or a brain MRI (including certain types of stroke or high levels of white matter changes on the scan)
• People with a history of bleeding in the brain, or serious bleeding in the digestive tract, lungs, nose, or skin
• People with severely reduced kidney function, or certain blood test values indicating kidney problems that are three or more times above the normal range
• People with moderate to severe liver problems, or liver-related blood test values that are three or more times above the normal range
• People with poorly controlled diabetes, shown by a blood sugar marker (HbA1c) above 9
• People with low white blood cell counts (below 3.5 K/μl)
• People with a history of a bowel blockage condition called paralytic ileus, or who currently have severe ongoing constipation
• People with a known allergy to the study drug (fasudil), or who have an established inflammatory or autoimmune condition
• People with significantly low blood pressure (below 90/60 mmHg) along with related symptoms such as rapid heartbeat, dizziness, or fainting
• People with a current significant diagnosis of depression or another mental health condition that could affect thinking or interfere with taking part in the study
• People who have had relevant changes to their medications within the past three months — participants must have been on stable Alzheimer's or antidepressant medications for at least three months before the study begins
• People using sedating (calming or sleep-inducing) medications — though short-acting sleep aids may be permitted if taken as directed and used stably for at least three months before the study starts (confirm with trial site)
• People currently enrolled in another drug trial
• People with a currently active life-threatening illness, such as advanced cancer, advanced heart disease, advanced lung disease, end-stage kidney disease, or advanced infectious disease
• People with any past or current neurological condition — unrelated to Alzheimer's disease — that has affected their thinking or memory
• People whose heart electrical activity test (ECG) shows a prolonged QTc interval — above 460 milliseconds for men or above 470 milliseconds for women

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