Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02002819 : Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
PhasePhase 2
AgesMin: 45 Years Max: 80 Years
Eligibility
To be included in the trial all of the following inclusion criteria must be met:

Ability to obtain written informed consent from the patient or caregiver as a surrogate;
Meets National Institute on Aging-Alzheimer's Association Workgroups criteria for probable
AD dementia (McKhann et al. 2011); Age = 80 years at time of screening; Willing and able
caregiver who has daily contact with the subject; Mini-Mental State Examination (MMSE)
score = 18 and/or Clinical Dementia Rating (CDR) < 2 at the initial screening assessment;
Subjects and caregivers must be able to comply with prescribed regime of study treatment
throughout the course of the study, and meet the required time commitment of four days of
in-person visits; Any concurrent treatment for AD approved by the Food and Drug
Administration (FDA), such as donepezil, galantamine, or rivastigmine, and memantine, must
be stable for at least 30 days prior to screening and at least 60 days prior to study day
1. Other medications (except those listed under exclusion criteria) are allowed as long as
the dose is stable for 30 days prior to screening.

The following criteria are considered grounds for exclusion:

Any conditions which could account for cognitive deficits in addition to AD, including but
not limited to Vitamin B12 or folate deficiency, abnormal thyroid function, posttraumatic
conditions, syphilis, multiple sclerosis or another neuroinflammatory disorder, Parkinson's
disease, vascular or multi-infarct dementia, Huntington's disease, normal pressure
hydrocephalus, central nervous system (CNS) tumor, progressive supranuclear palsy, subdural
hematoma, etc.; Previous history of a seizure disorder, excepting cases where the first
seizure or detection of epileptiform activity was within 5 years of screening and the
patient is not prescribed an anticonvulsant; Significant systemic medical illnesses; Use of
medications likely to affect CNS functions (e.g., benzodiazepines, narcotics); Severe renal
dysfunction with creatine clearance < 30 ml/min, which would affect serum LEV levels;
Participation in another AD clinical trial within 3 months of Screening, or any AD clinical
trial, such as a vaccine, that has potential long-term effects; Treatment with another
study drug or investigational drug within 30 days of Screening; Pregnant or lactating; Any
other medical condition which is determined by the investigators to potentially create an
undue risk for an adverse effect; Biomarker evidence unsupportive of a diagnosis of AD.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02002819      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740