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Prevent-SVD

CompletedPhase 2

Lacunar Intervention Trial 1 (LACI-1)

Preventing Cognitive Decline and Dementia From Cerebral Small Vessel Disease

Assets

Cilostazol / isosorbide mononitrate

Listed sites

2

Recruiting sites

-

Enrollment

57

actual

Study population

Mixed / unspecified dementia

Key I/E criteria

•Age ≥35•History of intracranial hemorrhage excluded

Primary endpoint

•Tolerability proportion of patients able to tolerate the target dose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2015-001953-33
Other grant252 (AS-PG-14-033)Alzheimer's Society UK
NCT IDNCT02481323
Org study IDPrevSVD-2015

Timeline

Milestones

Study first posted2015-06-25estimated
Study start2016-03actual (month precision)
Primary completion2017-08actual (month precision)
Study completion2017-11-30actual
Last update posted2018-01-19actual

Assets

Drug assets

Cilostazolisosorbide mononitrate

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age35 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Mild symptomatic ischaemic stroke in the past four years compatible with a clinical lacunar stroke syndrome, with brain magnetic resonance imaging or computed tomography scanning that is compatible with a symptomatic small subcortical (lacunar) infarct, or if no recent relevant infarct is visible, that excluded other cause for symptoms
•Age > 35 years
•Independent in activities of daily living (modified Rankin ≤2)
•Able to give consent themselves

Exclusion criteria

•Other significant active neurological illness present since suffering stroke (eg seizures, multiple sclerosis, brain tumour)
•Age < 35
•Montreal Cognitive Assessment score <26
•Requiring assistance with activities of daily living (Modified Rankin ≥3)
•Active cardiac disease (atrial fibrillation, myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
•Carotid stenosis > 50% in the symptomatic artery territory requiring carotid endarterectomy (prior and apparently successful carotid endarterectomy is not an exclusion criterion)
•Definite indication for, or definite contraindication to either trial drug
•Unable to swallow
•Bleeding tendency (platelets<100, taking anticoagulant medication)
•Unlikely to comply with trial medication
•Planned surgery during the trial period
•History of intracranial haemorrhage (subdural haematoma, subarachnoid haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic transformation of infarction)
•Other life threatening illness
•History of drug overdose or attempted suicide or significant active mental illness
•Pregnancy
•If recruited in Edinburgh and participating in cerebrovascular reactivity arm of trial: active respiratory illness (such as moderate to severe asthma or chronic obstructive airways disease), unable to tolerate magnetic resonance imaging or unable to lie flat

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
12
Neuroimaging
1
Other (unclassified)
1

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Efficacy - cerebrovascular function

Time frame:8 weeks

descriptive

Safety / tolerability / PK

12 endpoints
Primary/protocol endpoint

Tolerability proportion of patients able to tolerate the target dose

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Safety - bleeding

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Safety - recurrent stroke

Time frame:12 weeks

event count, event

Secondary/protocol endpoint

Safety - death

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Safety - blood pressure

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety - bleeding

Time frame:8 weeks

descriptive

Secondary/protocol endpoint

Tolerability Proportion of patients with headache that interferes with daily activities

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Tolerability Proportion of patients with dizziness that interferes with daily activities

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Tolerability Proportion of patients with nausea that interferes with daily activities

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Tolerability Proportion of patients with palpitations

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Tolerability Proportion of patients with loose stools

Time frame:8 weeks

threshold achievement, event

Secondary/protocol endpoint

Tolerability Tablet count

Time frame:8 weeks

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Efficacy - systemic arterial stiffness

Time frame:8 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.