Testing the cognitive effects of tadalafil. Neuropsychological secondary outcomes from the PASTIS trial.
Clinical trials
Cognitive testing
Pde5
Small vessel disease
Tadalafil
Vascular cognitive impairment
Vascular dementia
Journal
Cerebral circulation - cognition and behavior
ISSN: 2666-2450
Titre abrégé: Cereb Circ Cogn Behav
Pays: Netherlands
ID NLM: 101774849
Informations de publication
Date de publication:
2023
2023
Historique:
received:
04
05
2023
revised:
25
09
2023
accepted:
25
09
2023
medline:
9
10
2023
pubmed:
9
10
2023
entrez:
9
10
2023
Statut:
epublish
Résumé
Cerebral small vessel disease (SVD) is a major cause of cognitive impairment in older people. As secondary endpoints in a phase-2 randomised clinical trial, we tested the effects of single administration of a widely-used PDE5 inhibitor, tadalafil, on cognitive performance in older people with SVD. In a double-blinded, placebo-controlled, cross-over trial, participants received tadalafil (20 mg) and placebo on two visits ≥ 7 days apart (randomised to order of treatment). The Montreal Cognitive Assessment (MOCA) was administered at baseline, alongside a measure to estimate optimal intellectual ability (Test of Premorbid Function). Then, before and after treatment, a battery of neuropsychological tests was administered, assessing aspects of attention, information processing speed, working memory and executive function. Sixty-five participants were recruited and 55 completed the protocol ( http://www.clinicaltrials.gov. Unique identifier: NCT00123456, https://eudract.ema.europa.eu. Unique identifier: 2015-001,235-20NCT00123456.
Identifiants
pubmed: 37811523
doi: 10.1016/j.cccb.2023.100187
pii: S2666-2450(23)00031-4
pmc: PMC10550803
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100187Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
MMHP and LRB were employed as part of the PASTIS trial, JDI was Principal Investigator and AHH was Chief Investigator. CK is a PI on clinical trials funded by Bristol-Myers-Squibb and Bayer, and has received funding from NovoNordisk, all not relevant to the present trial. JDI has been a PI on clinical trials funded by Roche, Merck and Lupin Pharmaceuticals and has received funds from Nestle, Biogen and Roche, none relevant to the present trial. AHH leads MRC-Dementias Platform UK Vascular Experimental Medicine group. All other authors report no relevant disclosures. The trial was subject to an ICH-Good Clinical Practice (GCP) inspection by the UK medicines regulator, the MHRA, in September 2019, which identified a number of regulatory findings associated with the management of the trial. These are outlined in the supplementary information.
Références
J Psychopharmacol. 2020 Jan;34(1):103-114
pubmed: 31692397
Neuropsychopharmacology. 2009 Jul;34(8):1914-25
pubmed: 19262466
Br J Clin Pharmacol. 2007 Jan;63(1):24-35
pubmed: 16869816
Neuropharmacology. 2010 Nov;59(6):367-74
pubmed: 20493887
Neuropharmacology. 2013 Jan;64:114-23
pubmed: 22776546
J Int Neuropsychol Soc. 2000 May;6(4):469-79
pubmed: 10902416
Psychopharmacology (Berl). 2009 Jan;202(1-3):411-7
pubmed: 18716761
Br J Pharmacol. 2011 Dec;164(8):2029-41
pubmed: 21627640
Eur J Neurol. 2021 Dec;28(12):3883-3920
pubmed: 34476868
Arch Gerontol Geriatr. 2003 Nov-Dec;37(3):241-57
pubmed: 14511850
Neurobiol Aging. 2012 Mar;33(3):625.e11-20
pubmed: 21546125
J Alzheimers Dis Rep. 2020 Apr 22;4(1):91-106
pubmed: 32467879
Sci Rep. 2019 Nov 19;9(1):17119
pubmed: 31745217
J Stroke Cerebrovasc Dis. 2016 Mar;25(3):642-9
pubmed: 26738812
Acta Neuropathol. 2017 Aug;134(2):171-186
pubmed: 28488154
Int Urol Nephrol. 2001;32(3):409-12
pubmed: 11583362
Psychol Bull. 2012 Jul;138(4):628-654
pubmed: 22409508
J Neuropathol Exp Neurol. 2019 Feb 1;78(2):191-194
pubmed: 30590671
Neuropharmacology. 2012 Mar;62(3):1182-90
pubmed: 21856317
Alzheimers Dement. 2022 Dec;18(12):2393-2402
pubmed: 35135037
Trials. 2017 May 22;18(1):229
pubmed: 28532471
Int J Impot Res. 2011 May-Jun;23(3):109-14
pubmed: 21544084
Stroke. 2020 Jan;51(1):38-46
pubmed: 31752610
Cereb Circ Cogn Behav. 2021;2:100033
pubmed: 34950896
World J Urol. 2001 Feb;19(1):46-50
pubmed: 11289570
J Alzheimers Dis. 2016;52(1):295-302
pubmed: 26967220
J Neurol Neurosurg Psychiatry. 1997 Dec;63(6):749-53
pubmed: 9416809
Eur J Pharmacol. 2014 Dec 15;745:84-90
pubmed: 25446565
Neurochem Int. 2019 Jul;127:103-112
pubmed: 30592970
Psychopharmacology (Berl). 2006 Jan;183(4):439-45
pubmed: 16320087
BMC Psychiatry. 2021 Dec 9;21(1):617
pubmed: 34886841
ACS Chem Neurosci. 2012 Nov 21;3(11):832-44
pubmed: 23173065
Int Immunopharmacol. 2020 Aug;85:106581
pubmed: 32442900
Neuropharmacology. 2013 Nov;74:86-95
pubmed: 23357335
Neuropharmacology. 2018 Aug;138:151-159
pubmed: 29885420
Front Neurol. 2021 Oct 28;12:756887
pubmed: 34777227
Psychopharmacology (Berl). 2013 Jan;225(2):303-12
pubmed: 22855271
Nat Aging. 2021 Dec;1(12):1175-1188
pubmed: 35572351
Alzheimers Dement (N Y). 2023 Sep 25;9(3):e12412
pubmed: 37766832
Br J Clin Pharmacol. 2006 Mar;61(3):280-8
pubmed: 16487221
J Alzheimers Dis. 2014;42 Suppl 4:S561-73
pubmed: 25125473
Stroke. 2022 Feb;53(2):404-415
pubmed: 35000425