Study Summary
This trial is testing whether the drug levetiracetam can help improve cognition in patients with Alzheimer's disease by reducing cortical hyperexcitability and abnormalities in brain network function.
Eligible Conditions
- Alzheimer's Disease
- Mild Cognitive Impairment
- Alzheimer's Dementia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
8 Primary · 0 Secondary · Reporting Duration: From enrollment until the end of the treatment periods at 5 months
Baseline
Interictal Epileptiform Discharges
Month 5
Change in beta power after theta-burst stimulation
Change in motor evoked potential (MEP) amplitude
Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity
Neuropsychological Test Battery (NTB)
Resting-state electroencephalogram (EEG) beta band connectivity
Resting-state electroencephalogram (EEG) beta band power
Transcranial magnetic stimulation (TMS) resting motor threshold
Transcranial magnetic stimulation (TMS)-evoked N45 electroencephalogram (EEG) potential
Transcranial magnetic stimulation (TMS)-evoked electroencephalogram (EEG) hypersynchrony
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Levetiracetam
30%Somnolence
14%Dizziness
6%Sedation
6%Nausea
6%Headache
6%Fatigue
2%Convulsion
1%Grand mal convulsion
Trial Design
4 Treatment Groups
Healthy Control Group
1 of 4
Early Alzheimer's Disease Group Low Dose
1 of 4
Early Alzheimer's Disease Group High Dose
1 of 4
Early Alzheimer's Disease Group Placebo
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group
85 Total Participants · 4 Treatment Groups
Primary Treatment: Levetiracetam · Has Placebo Group · Phase 2
Early Alzheimer's Disease Group Low Dose
Drug
Experimental Group · 1 Intervention: Levetiracetam · Intervention Types: DrugEarly Alzheimer's Disease Group High Dose
Drug
Experimental Group · 1 Intervention: Levetiracetam · Intervention Types: DrugHealthy Control GroupNoIntervention Group · 1 Intervention: Healthy Control Group · Intervention Types:
Early Alzheimer's Disease Group Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral capsule · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment until the end of the treatment periods at 5 months
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
778 Previous Clinical Trials
844,348 Total Patients Enrolled
Eligibility Criteria
Age 50 - 90 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The subjects with early AD are those who have not yet developed symptoms of Alzheimer's disease.
You have a history of memory loss, difficulty with language, and a gradual decline in memory and other mental abilities.
You have a CDR of 0.5-1.0.
You have no abnormal neurologic exam findings.
You have a mini mental state examination score of at least 28.
Who else is applying?
What state do they live in?
| Pennsylvania | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How many prior treatments have patients received?
| 1 | 100.0% |
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Conditions
Cancer Related
Treatments