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Web End = Eur Arch Psychiatry Clin Neurosci (2016) 266:249259 DOI 10.1007/s00406-015-0632-y
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Web End = A retrospective classication of diagnoses in terms of DSM5 for patients included in randomized controlled trials of Ginkgo biloba extract EGb 761
Robert Hoerr1 Michael Zaudig2
Abstract When the early trials of Ginkgo biloba extract EGb 761 were conducted, different terms were used to denote ageing-associated neurocognitive disorders. With the fth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), a taxonomy covering dementia and pre-dementia stages of such disorders became available. DSM-5 diagnostic criteria for neurocognitive disorders (NCDs) were applied to patients with any type of ageing-associated cognitive impairment, including dementia, enrolled in randomized controlled clinical trials of EGb 761, taking into account the reported inclusion and exclusion criteria and patient characteristics at baseline. For 23 of 31 trials (74 %), the inclusion diagnoses could be classied as NCD in accordance with DSM-5. Thirteen trials enrolled patients with major NCD, four trials enrolled patients with mild NCD and six trials enrolled patients with NCD, who could not be classied unambiguously as having mild or major NCD. Although various terms were formerly used for neurocognitive disorders, the patients enrolled in the majority of clinical trials with EGb 761
could be classied retrospectively using modern DSM-5
diagnostic criteria.
Received: 24 February 2015 / Accepted: 3 August 2015 / Published online: 13 August 2015 The Author(s) 2015. This article is published with open access at Springerlink.com
Keywords DSM-5 Diagnosis Dementia Mild cognitive impairment Ginkgo biloba EGb 761
Introduction
When the earliest clinical trials of the dened, quantied Ginkgo biloba extract EGb 761 and some other drugs, then called nootropics, were conducted during the 1970s and 1980s, there was no widely accepted diagnostic term, let alone consensus diagnostic criteria, for what was later called ageing-associated cognitive decline (AACD) [1], cognitive impairment no dementia (CIND) [2] or mild cognitive impairment (MCI) [3, 4]. For cognitive impairment in the elderly, vaguely dened terms were often used, e.g.: organic brain syndrome, cerebral insufciency, impairment of cerebral performance, Hirnleistungsstrungen (German), troubles du vieillissement...