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 who are willing to take part in all study activities and have signed a consent form agreeing to participate.
• People who have a friend or family member who is in contact with them at least once a week and is willing to sign their own consent form and fill out study questionnaires.
• Female participants must either have gone through menopause (no periods for at least 12 months in a row with no other explanation) or have had a surgical procedure that prevents pregnancy (such as removal of the uterus, both ovaries, or tubal ligation).
• People who are sufficiently fluent in English to complete thinking and memory tests, as judged by the study investigator.
• People who have noticed changes or concerns about their own memory or thinking, as shown by a score above 7 on a specific questionnaire used at the screening visit.
• People who have a parent, sibling, or child who has been diagnosed with Alzheimer's disease or a type of dementia that may be related to Alzheimer's disease.
• People whose head circumference measures less than 60 centimetres.
• People whose results on a detailed thinking and memory assessment (called the TorCA) were within the normal range either at the screening visit or within the past 6 months, with two possible exceptions: a slightly low score in the area of planning and organisation may be acceptable if the investigator believes it is due to ADHD, and a slightly low score in language may be acceptable if English is not the person's first language.
• People who have had results within the normal range on at least one of several recognised thinking and memory tests (MoCA, Cogniciti Brain Health Assessment, or TorCA) within the past 6 months, or a normal MoCA result at the screening visit.
• People who show a specific pattern of brain activity in a particular memory-related brain region, detected during a specialised brain scan (BOLD fMRI), that is higher than average by a defined amount (confirm with trial site).

Who may not be able to join:

• People who have had an allergic reaction to levetiracetam (the study drug) or any of its ingredients in the past.
• People who have a significant brain or nervous system condition, including any form of cognitive impairment, a mini-stroke within the past 12 months, a seizure within the past 12 months, epilepsy, Parkinson's disease, stroke, multiple sclerosis, Huntington's disease, normal pressure hydrocephalus, a brain tumour (except certain small non-harmful ones, assessed case by case), bleeding between the brain and skull, a past brain injury with lasting effects on the nervous system, or known structural abnormalities in the brain.
• People with a significant or unstable mental health condition, including schizophrenia, bipolar disorder, depression that is not well-managed, a high score on a depression screening questionnaire, active thoughts of suicide in the past 3 months, any suicide-related behaviour in the past 3 months, hospitalisation or treatment for suicidal behaviour within the past 5 years, or significant behavioural or psychological symptoms in the past 3 months that could make study participation difficult.
• People with a known or suspected history of drug or alcohol misuse or dependence within the 2 years before the screening visit.
• People with a serious or unstable physical health condition that the investigator considers would make participation unsuitable, including a cancer diagnosis within the past 3 years (except certain minor skin cancers), or moderate to severe chronic kidney disease, chronic lung disease, or heart failure.
• People with certain findings on a recent brain MRI or CT scan, including severe changes to the brain's white matter, a significant stroke, certain types of small brain lesions, brain tissue damage, blood vessel abnormalities at high risk of bleeding, signs of infection, growths in the brain, or any other abnormality the investigator considers a concern.
• People who are unable to have an MRI or MEG brain scan for any reason, such as having a pacemaker, metal implants in the body, or severe claustrophobia.
• People who are currently taking, or would need to take during the study, any of the following medications: anti-seizure medications, methotrexate, or medications that block a chemical in the brain called acetylcholine (anticholinergic drugs).
• People whose kidney function, as measured by a blood test at screening, falls below a certain level.
• People whose heart electrical activity reading (ECG) shows a specific measurement (QTc interval) above a set threshold at screening.
• People whose screening blood test results show clinically significant abnormalities that the investigator considers would make participation unsuitable.

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