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Cognitive Deficits | Characterizing and Predicting Drug Effects on Cognition

Cognitive Deficits research study

What is the primary objective of this study?

Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a mild, untoward effect on an essential function such a linguistic behavior, a directly observable product of complex cognitive processes, is disruptive to daily life. Nevertheless, the mechanisms underlying a drug's impact on cognition are poorly understood. This lack of understanding impedes the ability to predict both the effects of drugs in development and the degree to which an individual is vulnerable to the cognitive impact of a particular agent. Topiramate (TPM, an antiepileptic drug) is, with increasing frequency, being prescribed for a range of conditions including migraine prophylaxis, obesity and pain. It is a prime example of a drug that causes speech and language problems severe enough in some patients to result in discontinuation of therapy. For reasons not well understood, TPM has a poorer cognitive profile than many of the older antiepileptic drugs. The investigators' rational for this study is that it will offer insight into the mechanisms underlying drug-induced cognitive deficits.

Who is eligible to participate?

Inclusion Criteria: - Healthy men and women - Ages 18-50 - Women are post-menopausal or using approved birth control methods - To control for brain lateralization of language functions, subjects need to have a dominant right hand. Exclusion Criteria: - Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, renal, neurologic, and/or psychiatric disease including suicidality - Vision or hearing impairments - Current or a history of drug or alcohol abuse - living outside of the Twin Cities Metropolitan area. - The use of concomitant medications known to affect Topiramate (TPM), Lorazepam (LZP), or the use of any concomitant medications that may alter cognitive function - Prior adverse reaction or prior hypersensitivity to TPM, LZP or related compounds - A positive pregnancy test (administered to all women before enrollment, and prior to each study session). - Subjects who have received any investigational drug within the previous 30 days

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cognitive Deficits

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TopiramateTopiramate: 100 mg, 150 mg or 200 mg, po, 1x

Drug:LorazepamLorazepam: 2mg, po, 1x

Other:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TopiramateTopiramate; 100mg, 150 mg or 200 mg, po,1x

LorazepamLorazepam: 2mg, po,1x

PlaceboPlacebo: one tablet, po,1x

Study Status

Completed

Start Date: July 2013

Completed Date: August 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Relationship between neurocognitive performance and study drug plasma concentration

Secondary Outcome: Neurophysiological effect of study drug on working memory

Study sponsors, principal investigator, and references

Principal Investigator: Susan E. Marino, PhD

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01889602

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