drugset / Trial / NCT01889602

Characterizing and Predicting Drug Effects on Cognition

NCT01889602

Phase 4 Completed 60 enrolled University of Minnesota
RandomizedCrossoverQuadruple-blindOther

Summary

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.

Timeline

Start
2013-07
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorazepam Small molecule 2 mg Oral
Subject Topiramate Small molecule 100 mg Oral
Subject Topiramate Small molecule 150 mg Oral
Subject Topiramate Small molecule 200 mg Oral

Indications