Preventing cognitive decline and dementia from cerebral small vessel disease

Conditions

Stroke due to cerebral small vessel disease Mental and Behavioural Disorders Subcortical vascular dementia

Gordon W. Blair, Esther Janssen, Michael S. Stringer, Michael J. Thrippleton, Francesca Chappell et al. (12 authors)

Stroke2021-12-0121 citations

10.1161/strokeaha.121.034866

Tolerability, safety and intermediary pharmacological effects of cilostazol and isosorbide mononitrate, alone and combined, in patients with lacunar ischaemic stroke: The LACunar Intervention-1 (LACI-1) trial, a randomised clinical trial.

Blair GW, Appleton JP, Flaherty K, Doubal F, Sprigg N, Dooley R, Richardson C, Hamilton I, Law ZK, Shi Y, Stringer MS, Thrippleton MJ, Boyd J, Shuler K, Bath PM, Wardlaw JM.

2019-04-2443 citations

10.1016/j.eclinm.2019.04.001

Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination

Gordon W. Blair, Jason P. Appleton, Zhe Kang Law, Fergus Doubal, Katie Flaherty et al. (16 authors)

International Journal of Stroke2017-09-1424 citations

10.1177/1747493017731947

Interventions

Participants will be randomised to one of four groups to take one or other drug or both starting immediately or both with a delayed start, the dose of each drug initially being started at low dose and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Mild symptomatic ischaemic stroke compatible with a lacunar ischaemic stroke in the past four years with brain magnetic resonance imaging or CT brain scanning that confirmed the relevant infarct or excluded other cause for symptoms 2. Age >35 years 3. Independent in activities of daily living (modified Rankin =2) 4. Able to give consent (Montreal Cognitive Assessment score 26-30)

Exclusion criteria

Exclusion criteria: 1. Other significant acute neurological illness since suffering stroke 2. Age 50% NASCET 6. Contraindication to trial drugs 7. Current use of trial drugs 8. Unable to swallow 9. Bleeding tendency 10. Unlikely to comply with trial medication 11. Planned surgery during the trial period 12. History of intracranial haemorrhage 13. Other life threatening illness 14. History of drug overdose or attempted suicide or significant active mental illness 15. Pregnancy

Design outcomes

Primary

Measure	Time frame
Number of patients reaching target dose judged on direct questioning, medication diary and tablet count	—

Secondary

Measure	Time frame
1. Symptoms of headache, palpitations, or loose stools (all present/absent and if present then degree of interference with daily life), dizziness (dizziness scale), nausea (nausea scale) assessed every two weeks during the trial 2. Safety (bleeding, recurrent vascular events, death) assessed at the end of the trial 3. Effect on blood pressure measured three times standing and sitting with an omron bp device assessed in weeks 3 and 8 4. Effect on platelet function measured with a specialised platelet function assay (platelet solutions) assessed in weeks 3 and 8 5. Effect on cerebrovascular reactivity measured with magnetic resonance imaging and carbon dioxide breathing challenge assessed in week 8 6. Effect on arterial stiffness measured using pulse wave velocity and pulse wave analysis assessed in week 3 and week 8	—

Measure

Time frame

1. Symptoms of headache, palpitations, or loose stools (all present/absent and if present then degree of interference with daily life), dizziness (dizziness scale), nausea (nausea scale) assessed every two weeks during the trial 2. Safety (bleeding, recurrent vascular events, death) assessed at the end of the trial 3. Effect on blood pressure measured three times standing and sitting with an omron bp device assessed in weeks 3 and 8 4. Effect on platelet function measured with a specialised platelet function assay (platelet solutions) assessed in weeks 3 and 8 5. Effect on cerebrovascular reactivity measured with magnetic resonance imaging and carbon dioxide breathing challenge assessed in week 8 6. Effect on arterial stiffness measured using pulse wave velocity and pulse wave analysis assessed in week 3 and week 8

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Countries

England, Scotland, United Kingdom

Contacts

Public ContactJulia Boyd

Julia.boyd@ed.ac.uk+44 (0)131 537 3842

Outcome results

None listed