Vascular Dementia Clinical Trials

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Vascular Dementia Clinical Trials

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Overview

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This page tracks active and recent clinical trials targeting vascular dementia (VaD), vascular cognitive impairment (VCI), and cerebral small vessel disease (CSVD). Unlike Alzheimer's disease, VaD has fewer disease-modifying therapies in development, with current focus on vascular risk modification, neuroprotection, and cognitive enhancement.

Pipeline Summary

| Phase | VaD/VCI Trials | Notes |
|-------|----------------|-------|
| Phase 1 | ~5 | Mostly targeting vascular mechanisms |
| Phase 2 | ~15 | Cognitive endpoints, BP modification |
| Phase 3 | ~10 | Largest studies focus on secondary prevention |

Phase 3 Trials

Intensive Blood Pressure Control

...

Overview

Mermaid diagram (expand to render)

This page tracks active and recent clinical trials targeting vascular dementia (VaD), vascular cognitive impairment (VCI), and cerebral small vessel disease (CSVD). Unlike Alzheimer's disease, VaD has fewer disease-modifying therapies in development, with current focus on vascular risk modification, neuroprotection, and cognitive enhancement.

Pipeline Summary

| Phase | VaD/VCI Trials | Notes |
|-------|----------------|-------|
| Phase 1 | ~5 | Mostly targeting vascular mechanisms |
| Phase 2 | ~15 | Cognitive endpoints, BP modification |
| Phase 3 | ~10 | Largest studies focus on secondary prevention |

Phase 3 Trials

Intensive Blood Pressure Control

SPRINT-MIND (NCT01206062)

Population: Adults with hypertension, aged ≥55 years
Intervention: Intensive BP control (SBP <120 mmHg) vs standard (<140 mmHg)
Outcome: Incident MCI, all-cause dementia, white matter lesion progression
Status: Completed
Key Finding: Intensive control reduced risk of mild cognitive impairment by 24% and combined MCI/dementia by 19%
Reference: https://clinicaltrials.gov/ct2/show/NCT01206062

Cerebral Small Vessel Disease

LACI-1 (NCT03131289)

Population: Lacunar stroke patients with small vessel disease
Intervention: Cilostazol + isosorbide mononitrate vs placebo
Outcome: Endothelial function, white matter lesion progression
Status: Completed
Key Finding: Combination therapy improved cerebrovascular reactivity

LACI-2 (ISRCTN10506409)

Population: Lacunar stroke survivors
Intervention: Dual antiplatelet therapy (clopidogrel + aspirin) vs aspirin alone
Outcome: Recurrent stroke, cognitive decline
Status: Completed
Reference: https://clinicaltrials.gov/ct2/show/NCT03131289

Phase 2 Trials

Neuroprotective Agents

Cerebrolysin Studies

Mechanism: Neurotrophic factor mixture
Phase: 2-3
Population: Vascular dementia patients
Outcomes: Cognitive function, global clinical impression
Status: Mixed results; larger trials needed

Citicoline (CDP-Choline)

Mechanism: Membrane stabilizer, supports acetylcholine synthesis
Phase: 2-3
Population: Vascular cognitive impairment
Outcomes: Memory, executive function
Note: Historical trials showed mixed results

Anti-inflammatory Approaches

MINDS (NCT02740984)

Population: Small vessel disease with cognitive impairment
Intervention: Minocycline (anti-inflammatory)
Outcome: White matter lesion progression, cognitive scores
Status: Completed

Endothelial Function

PROPEL (NCT02831188)

Population: Vascular cognitive impairment
Intervention: Propentofylline (phosphodiesterase inhibitor)
Outcome: Cerebral blood flow, cognitive function
Status: Completed

Phase 1 Trials

Novel Mechanisms

| Agent | Mechanism | Target | Status |
|-------|-----------|-------|--------|
| BTI202 | PDE5 inhibitor | Cerebral vasodilation | Phase 1 |
| NGP-5555 | Anti-amyloid (vascular) | CAA in VCI | Phase 1 |
| CNB-001 | Neuroprotective | Akt/GSK3β | Phase 1 |

Failed/Discontinued Trials

Phase 3 Failures

| Drug | Mechanism | Reason for Failure |
|------|------------|-------------------|
| Enoxaparin | Anticoagulant | Bleeding risk exceeded benefit |
| Xanapezine | Vasodilator | Lack of efficacy |
| S-(-)-efar | Calcium channel | Insufficient cognition benefit |

Lessons Learned

Single-target approaches limited: Multi-target therapies may be needed given the heterogeneous vascular pathology

Timing matters: Early intervention before significant white matter damage appears more effective

Mixed pathology: Many patients with VaD also have AD pathology, complicating trial design and endpoint selection

Biomarker Endpoints in VaD Trials

Imaging Biomarkers

White matter hyperintensity (WMH) volume: Primary imaging endpoint
Diffusion tensor imaging (DTI): Microstructural integrity
Cerebral blood flow (ASL): Perfusion measures
Susceptibility-weighted imaging (SWI): Microbleed detection

Fluid Biomarkers

| Biomarker | Utility |
|-----------|---------|
| Neurofilament light chain (NfL) | Axonal damage, disease progression |
| Glial fibrillary acidic protein (GFAP) | Astrocyte activation |
| Tau (total and phosphorylated) | Neuronal injury, AD co-pathology |
| Amyloid-beta 40/42 | AD co-pathology assessment |

Clinical Endpoints

MMSE: Global cognition
MoCA: Executive function sensitive
EXIT25: Frontal/executive function
Vascular Dementia Assessment Scale (VaDAS): VaD-specific
ADAS-Cog: Modified for vascular features

Ongoing Trials (2024-2026)

Cognitive Training + Vascular Control

Cog-VACS (NCT05287474)

Population: Post-stroke cognitive impairment
Intervention: Computerized cognitive training + BP management
Outcome: Composite cognitive score at 12 months
Status: Recruiting

Novel Anti-platelet

THALES-2 (NCT04676551)

Population: Acute lacunar stroke
Intervention: Ticagrelor + aspirin vs aspirin alone
Outcome: New ischemic lesions on MRI, cognitive function
Status: Recruiting

Genetic Subtype Studies

CADASIL-BMS (NCT04052737)

Population: CADASIL patients
Intervention: BMS-986012 (anti-Notch3)
Outcome: Safety, cognitive endpoints
Status: Phase 1

Key Research Centers

| Institution | Focus |
|-------------|-------|
| University of Edinburgh | CSVD imaging, white matter |
| UCL Institute of Neurology | Vascular cognitive impairment |
| University of Pittsburgh | Cerebral autoregulation |
| Maastricht University | CSVD genetics |
| Karolinska Institutet | Vascular mechanisms |

References

Moore, E. et al. (2019). Clinical Trials in Vascular Dementia: A Scoping Review. Alzheimer's & Dementia.

Pantoni, L. (2010). Cerebral small vessel disease: From pathogenesis to clinical challenges. Lancet Neurology.

Wardlaw, J.M. et al. (2019). Small vessel disease: Mechanisms and clinical implications. Lancet Neurology.

Dichgans, M. & Leys, D. (2017). Vascular Cognitive Impairment. Circulation Research.

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Related Entities

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📊 Evidence Profile Foundational

Evidence Balance

+0%

Certainty

100%

Debates

0

Incoming

24

Outgoing

28

0 supporting 0 contradicting 0 neutral

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📗 Cite This Artifact

Vascular Dementia Clinical Trials

Overview

Pipeline Summary

Phase 3 Trials

Intensive Blood Pressure Control

Overview

Pipeline Summary

Phase 3 Trials

Intensive Blood Pressure Control

Cerebral Small Vessel Disease

Phase 2 Trials

Neuroprotective Agents

Anti-inflammatory Approaches

Endothelial Function

Phase 1 Trials

Novel Mechanisms

Failed/Discontinued Trials

Phase 3 Failures

Lessons Learned

Biomarker Endpoints in VaD Trials

Imaging Biomarkers

Fluid Biomarkers

Clinical Endpoints

Ongoing Trials (2024-2026)

Cognitive Training + Vascular Control

Novel Anti-platelet

Genetic Subtype Studies

Key Research Centers

See Also

References

💬 Discussion