Levetiracetam for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Walter Reed National Military Medical Center, Bethesda, MD
Alzheimer Disease+1 More
Levetiracetam - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE)

See full description

Eligible Conditions

  • Alzheimer Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Levetiracetam will improve 1 primary outcome and 4 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Assessed at enrollment, week 7, week 15, week 27, and month 12.

Month 12
Change in Alzheimer's Disease Cooperative study - Clinical Global Impression of Change (ADCS-CGIC)
Change in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Change in EuroQol 5-Dimension (EQ-5D)
Change in Mini-Mental State Exam (MMSE)
Change in Neuropsychiatric Inventory Score (NPI)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Levetiracetam
Somnolence
30%
Dizziness
14%
Sedation
6%
Nausea
6%
Headache
6%
Fatigue
6%
Convulsion
2%
Grand mal convulsion
1%
Rash
0%
Bicytopenia
0%
Thermal burn
0%
Stevens-Johnson syndrome
0%
Lethargy
0%
Hallucination, auditory
0%
Coordination abnormal
0%
Adverse drug reaction
0%
Aggression
0%
Dengue fever
0%
Rash maculo-papular
0%
Anger
0%
Depressed level of consciousness
0%
Suicide attempt
0%
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

1 Treatment Group

Levetiracetam
1 of 1
Experimental Treatment

This trial requires 65 total participants across 1 different treatment group

This trial involves a single treatment. Levetiracetam is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Levetiracetam
Drug
All patients with epileptiform activity on initial screening EEG will receive levetiracetam for 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at enrollment, week 7, week 15, week 27, and month 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed at enrollment, week 7, week 15, week 27, and month 12 for reporting.

Closest Location

Walter Reed National Military Medical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
clinical note The MRI showed no evidence of a seizure focus, as outlined in the clinical note. show original
Reliable caregiver willing and available to assist with medication administration, outcome measures
meet the National Institute of Aging and Alzheimer's Association criteria for probable AD. show original
The patient has at least four symptoms from the Neuropsychiatric Inventory checklist. show original
MMSE <26
People taking medications such as acetylcholinesterase inhibitors should continue to do so for at least four weeks before enrolling in a clinical trial. show original

Patient Q&A Section

What are the signs of alzheimer disease?

"Clinically useful criteria for the diagnosis of AD exist, but clinicians frequently miss or incorrectly consider many previously described signs. In this sample, a positive association with the occurrence of major depressive disorder underscored the need for further investigation concerning the possibility of depression-related neurodegeneration." - Anonymous Online Contributor

Unverified Answer

Can alzheimer disease be cured?

"There is emerging evidence that the amyloid hypothesis is not wholly correct. This raises the possibility that, given we understand the biochemical pathways that are responsible for the spread of the amyloid plaque, we could develop treatments that target these pathways and thus treat AD appropriately. The possibility of halting AD in the prodromal stage raises the prospect of early diagnosis, treatment and possibly a cure for AD." - Anonymous Online Contributor

Unverified Answer

How many people get alzheimer disease a year in the United States?

"About 1.2 million people get AD during their lifetime. question: Does family history of Alzheimer disease affect age at onset in familial AD? answer: Findings from a recent study support the role of APOE4 allele in early onset for familial AD." - Anonymous Online Contributor

Unverified Answer

What causes alzheimer disease?

"Identifying environmental factors that are associated with increased risk of developing Alzheimer Disease in later life is a key step towards understanding the precise mechanisms of the disease. Further, as an understanding of the causes in earlier life may also lead to new therapies for late-onset Alzheimer's." - Anonymous Online Contributor

Unverified Answer

What is alzheimer disease?

"AD is a progressive, incurable brain disorder leading to cognitive and functional decline and, later, death. It is estimated that 8 million people are diagnosed with AD worldwide, and that 3.8 million died of AD in 2017. The disease is characterized by extracellular plaques and intracellular neurofibrillary tangles. Both factors are composed of beta-amyloid (Aβ) and Tau proteins. The two forms are deposited in the brain and spinal cord and trigger inflammatory and neurotoxic processes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alzheimer disease?

"Treatments of moderate efficacy can also be helpful to a majority of people with moderate to severe Alzheimer's and can help to keep people with this disease as independent and functional as possible as long as possible. Common treatments for AD are acetylcholinesterase inhibitors, memantine, and rasagiline for mild to moderate AD; donepezil and galantamine for moderate AD; and the Alzheimer's disease medication, galantamine, for moderate to severe AD." - Anonymous Online Contributor

Unverified Answer

Has levetiracetam proven to be more effective than a placebo?

"Levitiracetam treatment improves cognitive function. When patients already enrolled in a clinical trial receive a placebo in an additional treatment-phase, the placebo group has a higher cognitive performance than a placebo group already included into a clinical trial." - Anonymous Online Contributor

Unverified Answer

Does alzheimer disease run in families?

"The ADG family can be useful as a prospective cohort and model to investigate the genetic susceptibility to AD. However, the results obtained so far do not support the hypothesis of a substantial genetic contribution to familial AD and the role of modifier genes. Further studies, however, would be of great value to validate the existence of modifier genes for AD and other common diseases." - Anonymous Online Contributor

Unverified Answer

Is levetiracetam typically used in combination with any other treatments?

"Levetiracetam was typically used in combination with other treatments in this analysis, although there was a clear indication for the treatment of a patient's epilepsy. Levetiracetam was used to treat patients with both AD and epilepsy who had either had a prior history of seizure disorder or, as in this analysis, a history of epilepsy prior to onset of their AD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of levetiracetam?

"Levetiracetam is efficacious for the treatment of TIA but has a limited number of common side effects such as fatigue, dizziness, somnolence (drowsiness), headache, and tremor. Because of the incidence, degree, and duration, clinicians should be aware of these common side effects from levetiracetam and use it judiciously." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving levetiracetam?

"Currently there is no information on the adverse effects of LEV, and the existing data are limited given their small sample size. More, larger and longer-term studies are needed." - Anonymous Online Contributor

Unverified Answer

How does levetiracetam work?

"Although data are limited, levetiracetam seems to have a role as a monotherapy for dementia related to AD. Further trials are warranted to show its true role." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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