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Testing the cognitive effects of tadalafil. Neuropsychological secondary outcomes from the PASTIS trial.pdf (1014.16 kB)

Testing the cognitive effects of tadalafil. Neuropsychological secondary outcomes from the PASTIS trial

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posted on 2023-10-09, 16:06 authored by Mathilde MH Pauls, Barry MoynihanBarry Moynihan, Atticus H Hainsworth

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, placebocontrolled, 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 

Funding

UK Alzheimer’s Society and Alzheimer’s Drug Discovery Foundation (Grant Ref. 20140901)

National Institute for Health and Research Clinical Lectureship (CL-2015–16–001)

History

Comments

The original article is available at https://www.sciencedirect.com/

Published Citation

Pauls MMH. et al.Testing the cognitive effects of tadalafil. Neuropsychological secondary outcomes from the PASTIS trial. Cereb Circ Cogn Behav. 2023;5:100187

Publication Date

26 September 2023

PubMed ID

37811523

Department/Unit

  • Medicine

Publisher

Elsevier

Version

  • Published Version (Version of Record)