Levetiracetam for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alzheimer's Disease+2 MoreLevetiracetam - Drug
Eligibility
50 - 90
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2006 Phase 4 trial (NCT00160654) in the Levetiracetam ARM group. Side effects include: Somnolence with 30%, Dizziness with 14%, Sedation with 6%, Nausea with 6%, Headache with 6%.

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: Drug
Early Alzheimer's Disease Group High Dose
Drug
Experimental Group · 1 Intervention: Levetiracetam · Intervention Types: Drug
Healthy 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: Drug
Treatment
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?
Pennsylvania100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
1100.0%