Trial documents

Approved protocol

• Protocol v 4.0 26.11.2025.pdf   (updated 4 days ago)

Trial documents

• 10. LACI-3 Month 6 follow-up 20251218 v1.0.pdf   (updated 4 days ago)
• 11. LACI-3 Month 12 follow-up 20251218 v1.0.pdf   (updated 4 days ago)
• 12. LACI-3 Month 18 follow-up 20251218 v1.0.pdf   (updated 4 days ago)
• Baseline EQ5D5L EQ-VAS v 1.0 21 October 2024.pdf   (updated 4 days ago)
• Baseline Trail Making Test (TMT) Part B v 1.0 21 October 2024.pdf   (updated 4 days ago)
• Delgation Log v 1.0 26.02.2025.docx   (updated 4 days ago)
• Dose Escalation and Symptom Management Guide v 2.0 02.10.2025 Final.pdf
• Eligibility Assessment Guide v 3.0 25.09.25.pdf
• Eligibility Checklist v.4.0 10.12.2025.pdf
• Eligibility Recording v 1.0 12.06.2025.pdf
• File Note v 1.0 17.04.2025.docx   (updated 4 days ago)
• Medical staff Poster v 1.0 21.10.24.docx   (updated 21 days ago)
• MoCA-8.3-English-Instructions-2020.pdf   (updated 4 days ago)
• MoCA-8.3-English-Test-2020.pdf   (updated 4 days ago)
• Recruitment Checklist v.4.0 21.09.2025.pdf
• Recruitment Script v 2.0 17.11.2025.pdf

Information sheets and consent forms

• Contact Form v 2.0 27 January 2025.pdf   (updated 4 days ago)
• Facts Sheet 20241021 V1.0.pdf
• Participant Consent Form 20241021 V1.0.pdf
• Participant Information Sheet 20250516 V 3.0.pdf

Pharmacy documents

• Cilostazol 100 mg tablets - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf   (updated 4 days ago)
• Clinical Trial Drug Prescription Form v 2.0 05 February 2025.doc   (updated 4 days ago)
• Isodur 25XL Capsules - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf   (updated 4 days ago)
• Isosorbide Mononitrate Tablets 20 mg - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf   (updated 4 days ago)
• Study Specific IMP Label v 1.0 21 October 2024.pdf   (updated 4 days ago)
• Participant IMP Accountability Log v 1.0 12.11.2024.pdf   (updated 4 days ago)
• Pharmacy Manual v 1.0 12.02.2025.pdf   (updated 4 days ago)
• Representative Summary of Product Characteristics v 1.0 21.10.24 encrypted.pdf   (updated 4 days ago)
• Study PACK Cilostazol v 2.0 4 August 2025.docx
• Study PACK ISMN XL Cilostazol v 2.0 4 August 2025.docx
• Study PACK ISMN XL v 2.0 4 August 2025.docx
• Study PACK ISMN non-XL 20mg Cilostazol v 3.0 4 August 2025.docx
• Study PACK ISMN non XL 20 mg v 2.0 4 August 2025.docx

Sponsor
documents

• CR005-F02 Pregnancy Notification Form v8.0 (1).docx   (updated 4 days ago)
• DNA LACUNAR 2.pdf   (updated 4 days ago)
• GCP Deviation Log v5.0.docx   (updated 4 days ago)
• GCP Violation Reporting Form v6.0 (1).docx   (updated 19 days ago)
• OASIS.pdf   (updated 4 days ago)

REC documents

• 24-SS-0095-Updated FO On Further Info Letter 22-01-2024.pdf   (updated 4 days ago)

MHRA documents

• CTA Acceptance of Amended Request.pdf   (updated 4 days ago)

Substantial amendments

Minor amendments

• MA/08/26 /   (updated 4 days ago)
• MA/07/26 /   (updated 4 days ago)
• MA/06/26 /   (updated 4 days ago)
• MA/05/26 /   (updated 4 days ago)
• MA/04/25 /   (updated 4 days ago)
• MA/03/25 /   (updated 4 days ago)
• MA/02/25 /   (updated 4 days ago)

Trial working practice documents

• E-CRF Data Entry Manual V2.0 17092025.pdf   (updated 4 days ago)
• Follow-up Checklist v.1.0 19.01.26.pdf   (updated 20 days ago)
• IMP Re-supply for sites v 2.0 15.12.2025.pdf   (updated 20 days ago)
• Imaging Acquisition Guidelines LACI3 v.1.0 20250408.pdf   (updated 4 days ago)
• Imaging Transfer Guidelines v.1.0 20250408.pdf   (updated 4 days ago)
• Web upload guidelines v.1.0 LACI3 20250408.pdf   (updated 4 days ago)

Videos

• Webinar 1 - 23.09.2025.mp4
• Webinar 3-01.12.2025.mp4
• Webinar 4-20260119.mp4   (updated 11 days ago)
• Webinar 2-14.10.2025.mp4