title: Therapeutic development paths for cognitive impairment in Parkinson's disease: report of a regulatory roundtable.
abstract: Cognitive impairment is a common occurrence in Parkinson's disease (PD), although the severity and specific presentation varies across patients. Initial deficits, including mild cognitive impairment (PD-MCI), may remain stable or in many cases, may progress over variable lengths of time to Parkinson's disease dementia (PDD). As there are currently no marketed treatments for milder forms of cognitive impairment, an opportunity exists to define the path for therapeutic development in this area. In the absence of a well-defined path for the approval of therapies that target PD-MCI, pharmaceutical companies are unlikely to pursue this indication. In order to move forward and improve the quality of life for PD patients, it is imperative for the field to have consensus on the definition of PD-MCI, the best instruments to measure cognitive decline, and a strategy for future clinical trials.
authors.affiliation: Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.
authors.forename: Jamie
authors.initials: J
authors.lastname: Eberling
authors.affiliation: Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.
authors.forename: Lona
authors.initials: L
authors.lastname: Vincent
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Goldman
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Weintraub
authors.affiliation: Sant Pau Hospital, Barcelona, Spain.
authors.forename: Jaime
authors.initials: J
authors.lastname: Kulisevsky
authors.affiliation: University of Toronto, Toronto, Canada.
authors.forename: Connie
authors.initials: C
authors.lastname: Marras
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Glenn
authors.initials: G
authors.lastname: Stebbins
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D002986:Clinical Trials as Topic; D003072:Cognition Disorders / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy*; D018450:Disease Progression; D006801:Humans; D009483:Neuropsychological Tests; D010300:Parkinson Disease / Q000150:complications* / Q000523:psychology; D011788:Quality of Life
keywords: FDA; Parkinson's; clinical trial; cognition