Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT04004702
Eligibility Criteria:
Inclusion Criteria:
* Meet the National Institute of Aging-Alzheimer's Association criteria for probable AD
* Twelve-item Neuropsychiatric Inventory with score 4 or greater
* MMSE \<26
* Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry
* Reliable caregiver willing and available to assist with medication administration, outcome measures
* MRI completed with no evidence of potential seizure focus as outlined in the exclusion criteria
Exclusion Criteria:
* Imaging suggestive of potential seizure focus or alternative cause of dementia
* Previous Epilepsy diagnosis
* Use of anti-epileptic medication for any indication within previous three months
* History of head trauma with loss of consciousness more than 30 minutes
* Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years
* History of Korsakoff's syndrome
* History of encephalitis/meningitis
* Female participant who is pregnant, lactating or planning pregnancy during trial
* Scheduled elective surgery or other procedures requiring general anesthesia during the trial
* Participant with life expectancy of less than 12 months
* Any cancer requiring current chemotherapy
* Known allergy or history of previous adverse reaction to levetiracetam
* Major depression or other significant behavioral disturbance preceding Alzheimer's Disease diagnosis
* Enrollment in another clinical treatment trial
* Laboratory evidence of an alternative cause of dementia or which might preclude treatment, including untreated vitamin B12 deficiency, untreated hypothyroidism, syphilis, positive human immunodeficiency virus testing, end-stage renal disease on dialysis, significant renal impairment (creatinine clearance \<75 ml/minute), or liver function tests \>2x upper limit of normal within the preceding three months
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04004702
Study Brief:
Protocol Section:
NCT04004702