Dataset Information

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

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.

SUBMITTER: Pauls MM

PROVIDER: S-EPMC10550803 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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

Pauls Mathilde Mh MM Fish Jessica J Binnie Lauren R LR Benjamin Philip P Betteridge Shai S Clarke Brian B Dhillon Mohani-Preet K MK Ghatala Rita R Hainsworth Fearghal Ah FA Howe Franklyn A FA Khan Usman U Kruuse Christina C Madigan Jeremy B JB Moynihan Barry B Patel Bhavini B Pereira Anthony C AC Rostrup Egill E Shtaya Anan By AB Spilling Catherine A CA Trippier Sarah S Williams Rebecca R Young Robin R Barrick Thomas R TR Isaacs Jeremy D JD Hainsworth Atticus H AH

Cerebral circulation - cognition and behavior 20230926

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 As ...[more]

PMID: 37811523

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Project description:ObjectiveAshkenazi-Jewish (AJ) population-based BRCA testing is acceptable, cost-effective and amplifies primary prevention for breast & ovarian cancer. However, data describing lifestyle impact are lacking. We report long-term results of population-based BRCA testing on lifestyle behaviour and cancer risk perception.DesignTwo-arm randomised controlled trials (ISRCTN73338115, GCaPPS): (a) population-screening (PS); (b) family history (FH)/clinical criteria testing.SettingNorth London AJ-population.Population/sampleAJ women/men >18 years.Exclusionsprior BRCA testing or first-degree relatives of BRCA-carriers.MethodsParticipants were recruited through self-referral. All participants received informed pre-test genetic counselling. The intervention included genetic testing for three AJ BRCA-mutations: 185delAG(c.68_69delAG), 5382insC(c.5266dupC) and 6174delT(c.5946delT). This was undertaken for all participants in the PS arm and participants fulfilling FH/clinical criteria in the FH arm. Patients filled out customised/validated questionnaires at baseline/1-year/2-year/3-year follow-ups. Generalised linear-mixed models adjusted for covariates and appropriate contrast tests were used for between-group/within-group analysis of lifestyle and behavioural outcomes along with evaluating factors associated with these outcomes. Outcomes are adjusted for multiple testing (Bonferroni method), with P < 0.0039 considered significant.Outcome measuresLifestyle/behavioural outcomes at baseline/1-year/2-year/3-year follow-ups.Results1034 participants were randomised to PS (n = 530) or FH (n = 504) arms. No significant difference was identified between PS- and FH-based BRCA testing approaches in terms of dietary fruit/vegetable/meat consumption, vitamin intake, alcohol quantity/ frequency, smoking behaviour (frequency/cessation), physical activity/exercise or routine breast mammogram screening behaviour, with outcomes not affected by BRCA test result. Cancer risk perception decreased with time following BRCA testing, with no difference between FH/PS approaches, and the perception of risk was lowest in BRCA-negative participants. Men consumed fewer fruits/vegetables/vitamins and more meat/alcohol than women (P < 0.001).ConclusionPopulation-based and FH-based AJ BRCA testing have similar long-term lifestyle impacts on smoking, alcohol, dietary fruit/vegetable/meat/vitamin, exercise, breast screening participation and reduced cancer risk perception.

Dataset Information

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

Clinical trial registration

Publications

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

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