A systematic review of neuropsychiatric and cognitive assessments used in clinical trials for amyotrophic lateral sclero
- PDF / 838,308 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 199 Views
REVIEW
A systematic review of neuropsychiatric and cognitive assessments used in clinical trials for amyotrophic lateral sclerosis Emily Beswick1,2,4 · Emily Park3 · Charis Wong1,2,4 · Arpan R. Mehta1,2,4,6 · Rachel Dakin1,2 · Siddharthan Chandran1,2,4,6 · Judith Newton1,2 · Alan Carson1 · Sharon Abrahams4,5 · Suvankar Pal1,2,4 Received: 12 June 2020 / Revised: 27 August 2020 / Accepted: 29 August 2020 © The Author(s) 2020
Abstract Background Up to 50% of people with amyotrophic lateral sclerosis (ALS) experience cognitive dysfunction, whilst depression and anxiety are reported in up to 44% and 33%, respectively. These symptoms impact on quality of life, and are associated with a poorer prognosis. Historically, outcomes in clinical trials have focused on the effect of candidate drugs on physical functioning. Methods We reviewed the past 25 years of clinical trials of investigative medicinal products in people with ALS, since the licensing of riluzole, and extracted data on frequency and type of assessment for neuropsychiatric symptoms and cognitive impairment. Trial registry databases, including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed, were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 31/10/2019. No language restrictions were applied. Outcome measures, exclusion criteria and assessment tool used were extracted. Results 216 trials, investigating 26,326 people with ALS, were reviewed. 35% assessed neuropsychiatric symptoms, and 22% assessed cognition, as Exclusion Criteria or Outcome Measures. 3% (n = 6) of trials assessed neuropsychiatric symptoms as a Secondary Outcome Measure, and 4% (n = 8) assessed cognition as Outcome Measures; only one trial included assessments for both cognition and neuropsychiatric symptoms as Outcome Measures. Three ALS-specific assessments were used in six trials. Conclusions Trials for people with ALS have neglected the importance of neuropsychiatric symptoms and cognitive impairment. Evaluation of these extra-motor features is essential to understanding the impact of candidate drugs on all symptoms of ALS. PROPSERO registration CRD42020175612. Keywords Amyotrophic lateral sclerosis · Motor neuron disease · Neuropsychiatric · Cognition · Clinical trials
Introduction Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00415-020-10203-z) contains supplementary material, which is available to authorized users. * Suvankar Pal [email protected] 1
Centre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland
2
Anne Rowling Regenerative Neurology Clinic, 49 Little France Crescent, EH16 4SB, Edinburgh, UK
3
The School of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, Scotland
Amyotrophic lateral sclerosis (ALS) has been traditionally characterised as a disease of the motor system [1]; however, extra-motor symptoms, including neuropsychiatric 4
Data Loading...
