Treating Hyperexcitability in AD With Levetiracetam (NCT03875638) | Clinical Trial Compass
CompletedPhase 2
Treating Hyperexcitability in AD With Levetiracetam
United States58 participantsStarted 2019-08-22
Plain-language summary
The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria for the Subjects with early Alzheimer's Disease (AD)
* Age 50-90 years old.
* On a stable dose of medications for memory loss including cholinesterase inhibitors (for example: donepezil, rivastigmine or memantine) as defined by 4 consecutive weeks of treatment at an unchanging dose
* Meeting the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD.
* Mini Mental State Examination (MMSE) ≥ 20.
* Positive amyloid status (as defined by cerebral spinal fluid biomarkers or amyloid positron emission tomography (PET) study.
* Clinician Dementia Rating (CDR) of 0.5-1.0.
Inclusion Criteria for Healthy Control Subjects
* Age 50-90 years old.
* Normal neurologic exam
* Mini Mental State Examination (MMSE) \> 28
* Clinician Dementia Rating (CDR) of 0
Exclusion Criteria:
Exclusion Criteria Subjects with early Alzheimer's Disease
* Diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist. Evidence of epileptiform discharges and electroencephalogram (EEG) abnormalities will be included;
* Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuropsychological Test Battery (NTB)
Timeframe: From enrollment until the end of the treatment periods at 5 months
2
Transcranial magnetic stimulation (TMS) resting motor threshold
Timeframe: From enrollment until the end of the treatment periods at 5 months
3
Transcranial magnetic stimulation (TMS)-evoked electroencephalogram (EEG) hypersynchrony
Timeframe: From enrollment until the end of the treatment periods at 5 months
4
Resting-state electroencephalogram (EEG) beta band power
Timeframe: From enrollment until the end of the treatment periods at 5 months
5
Resting-state electroencephalogram (EEG) beta band connectivity
Timeframe: From enrollment until the end of the treatment periods at 5 months
6
Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity
Timeframe: From enrollment until the end of the treatment periods at 5 months