1. Testing the cognitive effects of tadalafil. Neuropsychological secondary outcomes from the PASTIS trial
- Author
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Mathilde MH Pauls, Jessica Fish, Lauren R Binnie, Philip Benjamin, Shai Betteridge, Brian Clarke, Mohani-Preet K Dhillon, Rita Ghatala, Fearghal AH Hainsworth, Franklyn A Howe, Usman Khan, Christina Kruuse, Jeremy B Madigan, Barry Moynihan, Bhavini Patel, Anthony C Pereira, Egill Rostrup, Anan BY Shtaya, Catherine A Spilling, Sarah Trippier, Rebecca Williams, Robin Young, Thomas R Barrick, Jeremy D Isaacs, and Atticus H Hainsworth
- Subjects
Clinical trials ,Tadalafil ,Pde5 ,Small vessel disease ,Vascular cognitive impairment ,Vascular dementia ,Specialties of internal medicine ,RC581-951 ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
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 (N = 55, age: 66.8 (8.6) years, range 52–87; 15/40 female/male). Median MOCA score was 26 (IQR: 23, 27], range 15–30). No significant treatment effects were seen in any of the neuropsychological tests. There was a trend towards improved performance on Digit Span Forward (treatment effect 0.37, C.I. 0.01, 0.72; P = 0.0521). We did not identify significant treatment effects of single-administration tadalafil on neuropsychological performance in older people with SVD. The trend observed on Digit Span Forward may help to inform future studies. Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00123456, https://eudract.ema.europa.eu. Unique identifier: 2015–001,235–20NCT00123456.
- Published
- 2023
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