Phase 3 Epilepsy Trial, Recruiting

Written by an AI model from the 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 who have been diagnosed with Down Syndrome, either confirmed by a chromosome test or by typical physical characteristics associated with the condition.
• People who are over 40 years old at the time of their initial screening assessment.
• People who have been diagnosed with Alzheimer's disease dementia that is causing noticeable symptoms, based on changes in daily functioning and results from memory and thinking tests (specific score thresholds are used depending on the person's level of intellectual disability).
• People who have a willing and able caregiver who sees them every day and can support their participation throughout the trial.
• People whose caregivers are able to commit to attending in-person visits at least twice a year for the duration of the trial.
• People who are already taking any European Medicines Agency (EMA)-approved Alzheimer's treatment, provided that treatment has been at a stable dose for at least 30 days before screening and at least 60 days before the trial officially begins.
• People, and/or their caregivers, who are able to give informed consent before any trial-related procedures take place.

Who may not be able to join:

• People whose memory or thinking difficulties appear to be caused by something other than Alzheimer's disease, such as uncorrected vision or hearing problems, severe untreated sleep apnea, or an uncontrolled thyroid condition.
• People who have a history of epileptic seizures that began in adulthood (after age 18).
• People who are currently taking anti-epileptic medications, benzodiazepines (a type of sedative), or narcotic medications.
• People with serious or unstable health conditions that the trial doctors believe could interfere with assessing how safe or effective the treatment is — for example, moderate or severe untreated sleep apnea, significantly low vitamin B12 or folate levels, abnormal thyroid function, stroke, or other conditions affecting blood flow to the brain.
• People with severely reduced kidney function, which could affect how the body processes the study medication, or any other medical condition that the investigators believe could create an unacceptable health risk.
• People with a current or past history of a psychiatric or neurological condition not related to Alzheimer's disease — for example, a significant head injury with loss of consciousness, stroke with symptoms, Parkinson's disease, severe narrowing of the carotid arteries, or mini-strokes (TIAs).
• People assessed as having a significant risk of suicide, based on a standardised assessment tool used in the trial (confirm with trial site for details).
• People with blood test results — including blood cell counts, liver function, or other biochemical measures — that the trial doctors consider to be clinically significant abnormalities.
• People who have taken part in another clinical trial within the 3 months before screening.
• People who have a known allergy or sensitivity to the active ingredient in the study medication, related compounds, or any other ingredients in the formulation.
• People who are pregnant or breastfeeding.

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