Preventing cognitive decline and dementia from cerebral small vessel disease

Phase 2

Completed

• Conditions: Stroke due to cerebral small vessel disease; Mental and Behavioural Disorders; Subcortical vascular dementia

• Registration Number: ISRCTN12580546
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28906205 protocol and statistical analysis plan 2019 Results article in https://doi.org/10.1016/j.eclinm.2019.04.001 results (added 25/06/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31333572 safety data results (added 25/07/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34847709/ (added 17/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-05
• Study Completion: 2017-10-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

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

1. Other significant acute neurological illness since suffering stroke
2. Age <35
3. Requiring assistance with activities of daily living (Modified Rankin =3)
4. Active cardiac disease (myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
5. Carotid stenosis >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients reaching target dose judged on direct questioning, medication diary and tablet count

Secondary Outcome Measures

Name	Time	Method
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 <br>2. Safety (bleeding, recurrent vascular events, death) assessed at the end of the trial<br>3. Effect on blood pressure measured three times standing and sitting with an omron bp device assessed in weeks 3 and 8<br>4. Effect on platelet function measured with a specialised platelet function assay (platelet solutions) assessed in weeks 3 and 8<br>5. Effect on cerebrovascular reactivity measured with magnetic resonance imaging and carbon dioxide breathing challenge assessed in week 8<br>6. Effect on arterial stiffness measured using pulse wave velocity and pulse wave analysis assessed in week 3 and week 8