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Recruiting NCT06148051

NCT06148051 AusCADASIL: An Australian Cohort of CADASIL

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Clinical Trial Summary
NCT ID NCT06148051
Status Recruiting
Phase
Sponsor Perminder Sachdev
Condition Cadasil
Study Type OBSERVATIONAL
Enrollment 300 participants
Start Date 2023-11-25
Primary Completion 2027-03-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 300 participants in total. It began in 2023-11-25 with a primary completion date of 2027-03-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The aim of this project is to establish an Australian cohort of patients diagnosed with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL). This study will examine the clinical features and longitudinal course of CADASIL. Outcome measures include neuropsychological profile, neuroimaging, genetics, blood biomarkers, and retinal imaging.

Eligibility Criteria

Inclusion criteria: 1. Adults ≥18 years old 2. Ability to provide written informed consent * A large-print version is available for individuals with visual impairment * An easy-to-read version is available for individuals with cognitive difficulties who may require extra support 3. Ability to attend a testing site 4. Ability to complete minimum dataset (medical examination and medical history questionnaire, blood test to determine genetic status and a short (20 minute) neuropsychology assessment). 5. CADASIL participants according to one of the following categories: 1. confirmed diagnosis via genetic testing (NOTCH3 pathogenic variant), OR 2. suspected diagnosis based on medical history and brain MRI, OR 3. first degree relative of participant who is positive for NOTCH3 pathogenic variant OR 6. Unrelated individual who is negative for the NOTCH3 pathogenic variant, and has no cognitive complaints (i.e. control participant) Exclusion criteria: 1\. Significant cognitive impairment leading to an inability to provide informed consent.

Contact & Investigator

Central Contact

Danit Saks, MBMSc, MRes, PhD

✉ d.saks@unsw.edu.au

📞 9348 1658

Principal Investigator

Perminder S Sachdev, MBBS, MD, PhD, FRANZCP, FAAHMS

PRINCIPAL INVESTIGATOR

University of New South Wales

Frequently Asked Questions

Who can join the NCT06148051 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Cadasil. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06148051 currently recruiting?

Yes, NCT06148051 is actively recruiting participants. Contact the research team at d.saks@unsw.edu.au for enrollment information.

Where is the NCT06148051 trial being conducted?

This trial is being conducted at Newcastle, Australia, Sydney, Australia, Sydney, Australia, Brisbane, Australia and 1 additional location.

Who is sponsoring the NCT06148051 clinical trial?

NCT06148051 is sponsored by Perminder Sachdev. The principal investigator is Perminder S Sachdev, MBBS, MD, PhD, FRANZCP, FAAHMS at University of New South Wales. The trial plans to enroll 300 participants.

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