Abstract Background and aims Cerebral small vessel disease (SVD) is a major cause of vascular cognitive impairment and currently no pharmacological therapy has proven to modify disease progression. Prior LACI trials suggested that isosorbide mononitrate (ISMN) and cilostazol may improve microvascular function and are well tolerated in a lacunar stroke patient population. Methods LACI-Cognition1 is an early feasibility trial assessing recruitment, tolerability, and safety of these medications in participants with vascular mild cognitive impairment due to cerebral SVD. Results This single-centre, randomised, phase-2 trial seeks to recruit 60 adults aged ≥50 years with cognitive impairment due to SVD from memory clinics. Participants are randomised to ISMN, cilostazol, both, or neither, for eight weeks, with two further weeks of follow-up. Cognitive, functional, and physical assessments will be undertaken by researchers blinded to group allocation. Structural MRI, MRI cerebrovascular reactivity, pulse wave analysis and retinal vessel reactivity will be performed before and after treatment where feasible. Symptoms, adherence, adverse effects, and adverse events will also be collected. Conclusions Outcomes will assess the feasibility of recruitment and retention, drug tolerability and safety, and the practicality of collecting cognitive, functional, and neuroimaging measures in this patient population. Secondary aims will explore whether cilostazol and ISMN, alone or in combination, lead to measurable short-term improvements in clinical outcomes- including cognition and neuroimaging markers. Conflict of interest
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Daniela Jaime Garcia
MRC Centre for Regenerative Medicine
Tim Wilkinson
MRC Centre for Regenerative Medicine
Tom Russ
Alzheimer Scotland
European Stroke Journal
University of Edinburgh
UK Dementia Research Institute
MRC Centre for Regenerative Medicine
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Garcia et al. (Fri,) studied this question.
synapsesocial.com/papers/69fd7ef7bfa21ec5bbf07434 — DOI: https://doi.org/10.1093/esj/aakag023.2062
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