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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 fifth 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 classified 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 classified 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 classified retrospectively using modern DSM-5 diagnostic criteria.Electronic supplementary materialThe online version of this article (doi:10.1007/s00406-015-0632-y) contains supplementary material, which is available to authorized users.
Highlights
When the earliest clinical trials of the defined, quantified Ginkgo biloba extract EGb 761® and some other drugs, 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]
The diagnostic criteria for major neurocognitive disorders (NCDs) or dementia of the classifications used in the included trials are presented in Table 1, arranged in a way to highlight the features in common and the differences
It can be concluded that all patients diagnosed with dementia using one of the sets of criteria listed in Table 1 can safely be classified as having major NCD in accordance with DSM-5
Summary
When the earliest clinical trials of the defined, quantified Ginkgo biloba extract EGb 761® and some other drugs, 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]. The DSM-III [5] already provided a description and diagnostic criteria for dementia and research diagnostic criteria for Alzheimer’s disease (AD) [6] and vascular dementia (VaD) [7] followed soon. In addition to the DSM criteria, the diagnostic criteria of the International Classification of Diseases (ICD-10) [10] were used in clinical trials. Descriptive terms that were neither precisely defined nor part of the thesaurus of a systematic classification of diseases were often used for conditions
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