CadasilNCT06148051
AusCADASIL: An Australian Cohort of CADASIL
An observational study of Cadasil, run by Perminder Sachdev at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cadasil
- How many people
- 300 participants
- Where
- 5 sitesAustralia
- Study dates
- 25 Nov 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with CADASIL confirmed by genetic testing, suspected due to clinical symptoms, or family history of CADASIL. Control cohort will be negative for the NOTCH3 pathogenic variant and have no cognitive complaints
Who may be able to join
- Adults ≥18 years old
- 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
- Ability to attend a testing site
- Ability to complete minimum dataset (medical examination and medical history questionnaire, blood test to determine genetic status and a short (20 minute) neuropsychology assessment).
Show all 11Show fewer
- CADASIL participants according to one of the following categories:
- confirmed diagnosis via genetic testing (NOTCH3 pathogenic variant), OR
- suspected diagnosis based on medical history and brain MRI, OR
- 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)
Who cannot join
- 1. Significant cognitive impairment leading to an inability to provide informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Not yet recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006
Michael O'Sullivan, MD, 3646 8111 ext. +617, m.osullivan1@uq.edu.au
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3052
Ashley Park, MD, 9342 7000 ext. +613, ashley.park@mh.org.au
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Beata Bajorek, BPharm DipHospPharm PhD, 4055 0650 ext. +612, Beata.Bajorek@newcastle.edu.au
- Recruiting
Prince of Wales Hospital
Sydney, New South Wales, 2031
Danit Saks, PhD, 93481658 ext. +61 2, d.saks@unsw.edu.au
- Recruiting
University of New South Wales
Sydney, New South Wales, 2031
Danit Saks, PhD, 93481658 ext. +61 2, d.saks@unsw.edu.au
About this study
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.
Read the detailed description
Using clinical examination, questionnaires, neuropsychological evaluation, brain MRI, blood sample evaluation and retinal imaging, we aim to characterise the clinical profile and progression of CADASIL in an Australian cohort.
This is multi-centre observational cohort study currently based at six sites (clinics, hospitals and universities) across three states in Australia (New South Wales, Victoria and Queensland). The multidisciplinary team aims to be the first to develop an Australian cohort of CADASIL which will contribute to global efforts and understanding of the disease.
- Conditions
- Cadasil
- Keywords
- CADASIL, Clinical Research, Genetics, Cognition, Neuroimaging, Blood markers, Retinal imaging
- Medical subject headings
- CADASIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CADASIL cohort | Not described | |
| Control Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online Medical Questionnaire
Includes questions on participant's medical history (CADASIL and other), family history, and medication use. Outcome will be used to inform clinical profile
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Weight and height will be combined to report BMI in kg/m^2
Participants will undergo structured physical examination which will provide further details on their clinical profile.
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Blood Pressure
Participants will undergo structured physical examination which will provide further details on their clinical profile. Systolic/diastolic blood pressure will be recorded 3 times during the physical examination
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Modified Rankin Scale (mRS)
Participants will undergo structured physical examination which will provide further details on their clinical profile. Scale from 0-5 (0 no symptoms, 5 severe disability)
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
National Institute of Health Stroke Scale (NIHSS)
Participants will undergo structured physical examination which will provide further details on their clinical profile. Individual items (11) relating to stroke symptoms and disability, for each item 0 indicates normal.
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Alphabet required for Trail Making A/B
As part of the neuropsychological battery, participants will need to complete the alphabet to inform ability to complete Trail Making tests A and B. These indicate executive function
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Montreal Cognitive Assessment (MoCA)
As part of the neuropsychological battery, participants will complete the MoCA to provide a measure of global cognitive function
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Category Fluency (animals)
As part of the neuropsychological battery, participants will complete Category Fluency to provide a measure of processing speed
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Digit Span Backwards (WAIS-IV)
As part of the neuropsychological battery, participants will complete digit span backwards to provide a measure of executive function
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
National Institute of Health Computerised Toolbox (NIHCTB)
As part of the neuropsychological battery, participants will complete the NIHCTB to provide measures of global function
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Letter Fluency (FAS)
As part of the neuropsychological battery, participants will complete the FAS to provide measures of executive function
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Rey Auditory Verbal Learning Test (RAVLT)
As part of the neuropsychological battery, participants will complete the RAVLT to provide measures of learning and memory
Measured: Baseline, Year 1, Year 2, Year 3, Year 4
Brain MRI scan (total scan time 60 mins)- includes T1 weighted imaging
To assess brain morphology
Measured: Baseline, Year 3
Brain MRI scan (total scan time 60 mins)- includes T2-weighted fluid attenuated inversion recovery (FLAIR) imaging
Combined with T1 outcome to assess brain morphology
Measured: Baseline, Year 3
Brain MRI scan (total scan time 60 mins)- includes susceptibility-weighted MRI
Assesses cerebral microbleeds. Signal magnitude will be processed to estimate signal decay time (i.e., T2* maps), which reflect compartmentalisation of magnetised tissue constituents (iron, calcium) [22]. Signal phase will be processed for quantitative susceptibility mapping.
Measured: Baseline, Year 3
Brain MRI scan (total scan time 60 mins)- includes multi-shell diffusion weighted MRI
Measures of brain white matter microstructural integrity, such as fractional anisotropy and mean diffusivity, will be calculated using tensor models. Fixel-based analyses of fibre density and cross-section will also be performed. Markers of cerebrovascular diseases derived from diffusion data, such as Peak width of Skeletonised Mean Diffusivity (PSMD), will be calculated. Structural connectivity will also be examined.
Measured: Baseline, Year 3
Brain MRI scan (total scan time 60 mins)- includes pseudo-continuous arterial spin labelling (PCASL) perfusion imaging with multiple post-labelling delays.
Used to assess quantitative cerebral blood flow and arterial transit time.
Measured: Baseline, Year 3
Brain MRI scan (total scan time 60 mins)- includes resting-state blood oxygenation level dependent (BOLD) imaging.
Used to assess brain functional activity and amplitude of low-frequency fluctuations which embeds signal of cerebrovascular reactivity. For sites with available capnography monitors, participants' end-tidal carbon dioxide concentrations will be recorded during acquiring resting-state BOLD data for more accurate quantification of cerebrovascular reactivity
Measured: Baseline, Year 3
Secondary outcomes (23)
Blood biochemistry
Analysed by local pathology lab to indicate clinical profile. Measures will include fasting glucose, HbA1c, lipids, C-reactive protein, creatinine, vit D and liver function tests.
Measured: Baseline, Year 3
Ocular Questionnaire
Includes questions regarding vision ability and ocular symptoms, and history
Measured: Baseline, Year 3
Genetic Profile
Genetic testing for NOTCH3 variants as well as potentially modifying genes
Measured: Baseline
Instrumental Activities of Daily Living Scale (IADL)
Completed online, 8 items to assess daily living skills in older adults. Outcome will be used to inform clinical profile
Measured: Baseline
Quality of Life Scale (EQ-5D-5L)
Completed online, 6 items to assess mobility, self-care, activities, pain/discomfort, anxiety/depression. Outcome will be used to inform clinical profile
Measured: Baseline
STOP-BANG Sleep Questionnaire
Completed online, 8 items to assess Obstructive Sleep Apnoea risk. Outcome will be used to inform clinical profile
Measured: Baseline
PROMIS Sleep Disturbance
Completed online, 8 items to assess sleep quality. Outcome will be used to inform clinical profile
Measured: Baseline
Apathy Evaluation Scale (AES)
Completed online, 18 items to assess apathy by goal-directed behaviour, goal-related cognition, and goal-related emotional responses. Outcome will be used to inform clinical profile
Measured: Baseline
Multidimensional Fatigue Inventory (MFI)
Completed online, 20 items to assess physical and mental fatigue and motivation. Outcome will be used to inform clinical profile
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Completed online, 9 items to assess depression symptoms and severity. Outcome will be used to inform clinical profile
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
Completed online, includes 14 items to assess non-physical symptoms of anxiety and depression. Outcome will be used to inform clinical profile
Measured: Baseline
Study Partner Apathy Evaluation Scale (AES)
Completed online by nominated study partner (someone who knows the participant well e.g. spouse, carer, friend etc). Inform's participant's apathy by goal-directed behaviour, goal-related cognition, and goal-related emotional responses
Measured: Baseline
Study Partner Instrumental Activities of Daily Living Scale (IADL)
Completed online by nominated study partner (someone who knows the participant well e.g. spouse, carer, friend etc). 8 items to assess daily living skills in older adults. Outcome will be used to inform participant's clinical profile
Measured: Baseline
Neuropsychiatric Inventory (NPI-Q)
Completed online by nominated study partner (someone who knows the participant well e.g. spouse, carer, friend etc). 12 domains, approx. 100 questions. Used to inform psychopathology in participants
Measured: Baseline
Blood Omic investigation
Blood tubes will be transported to the University of New South Wales for genomics, proteomics, lipidomics, and epigenomics analysis
Measured: Baseline and year 3
Ocular Assessment-Visual Acuity
a measure of the vision function using high contrast letters will be performed with standardised vision charts at distance and at near.
Measured: Baseline and year 3
Ocular Assessment- Contrast Sensitivity
A measure of vision function, relating to the ability to distinguish between an object and the background behind it.
Measured: Baseline and year 3
Ocular Assessment- Stereopsis
The perception of depth will be measured using a stereo acuity instrument by viewing a series of stereograms.
Measured: Baseline and year 3
Ocular Assessment- Slit-lamp examination
Involves viewing of the ocular structures using a slit-lamp illumination system and biomicroscope viewing system. The slit-lamp examination will be conducted by a trained observer and will allow identification of ocular media opacities, abnormalities of the eye lids, tear film and anterior structures.
Measured: Baseline and year 3
Ocular Assessment- Standard automated perimetry
A measure of the sensitivity of the visual field.
Measured: Baseline and year 3
Ocular Assessment- Intraocular pressure
A measure of the pressure within the eye.
Measured: Baseline and year 3
Ocular Assessment- Fundus imaging (requires pupil dilation using tropicamide 0.5 or 1.0% eye drops
Used to visualise the back of the eye
Measured: Baseline and year 3
Ocular Assessment- Optical Coherence Tomography (OCT) and OCT-Angiography
Used to visualise the back of the eye in retinal layers, and the retinal vessels
Measured: Baseline and year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start25 Nov 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CadasilStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perminder Sachdev
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Sydney, John Hunter Hospital, St Vincent's Hospital - Sydney, Australia, Royal Brisbane and Women's Hospital, Melbourne Health, The University of Queensland
- Responsible party
- Sponsor-investigator, Perminder Sachdev, The University of New South Wales
- Investigators
- Perminder S Sachdev, MBBS, MD, PhD, FRANZCP, FAAHMS, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148051
- Sponsor's protocol ID
- AusCADASIL
- Status last verified
- May 2024
- First submitted
- 7 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AusCADASIL: An Australian Cohort of CADASIL
- ClinicalTrials.gov ID
- NCT06148051
- Acronym / sponsor ID
- AusCADASIL
- Conditions
- Cadasil
- Keywords
- CADASIL, Clinical Research, Genetics, Cognition, Neuroimaging, Blood markers, Retinal imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Perminder SachdevUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Sydney, John Hunter Hospital, St Vincent's Hospital - Sydney, Australia, Royal Brisbane and Women's Hospital, Melbourne Health, The University of Queensland
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using clinical examination, questionnaires, neuropsychological evaluation, brain MRI, blood sample evaluation and retinal imaging, we aim to characterise the clinical profile and progression of CADASIL in an Australian cohort.
This is multi-centre observational cohort study currently based at six sites (clinics, hospitals and universities) across three states in Australia (New South Wales, Victoria and Queensland). The multidisciplinary team aims to be the first to develop an Australian cohort of CADASIL which will contribute to global efforts and understanding of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADASIL cohort | – | – |
| Control Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with CADASIL confirmed by genetic testing, suspected due to clinical symptoms, or family history of CADASIL. Control cohort will be negative for the NOTCH3 pathogenic variant and have no cognitive complaints
Key inclusion criteria (11 listed)
- Adults ≥18 years old
- Ability to provide written informed consent
- Ability to attend a testing site
- Ability to complete minimum dataset (medical examination and medical history questionnaire, blood test to determine genetic status and a short (20 minute) neuropsychology assessment).
- CADASIL participants according to one of the following categories:
Key exclusion criteria (1 listed)
- 1. Significant cognitive impairment leading to an inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Online Medical Questionnaire
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
Includes questions on participant's medical history (CADASIL and other), family history, and medication use. Outcome will be used to inform clinical profile
Weight and height will be combined to report BMI in kg/m^2
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
Participants will undergo structured physical examination which will provide further details on their clinical profile.
Blood Pressure
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
Participants will undergo structured physical examination which will provide further details on their clinical profile. Systolic/diastolic blood pressure will be recorded 3 times during the physical examination
Modified Rankin Scale (mRS)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
Participants will undergo structured physical examination which will provide further details on their clinical profile. Scale from 0-5 (0 no symptoms, 5 severe disability)
National Institute of Health Stroke Scale (NIHSS)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
Participants will undergo structured physical examination which will provide further details on their clinical profile. Individual items (11) relating to stroke symptoms and disability, for each item 0 indicates normal.
Alphabet required for Trail Making A/B
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will need to complete the alphabet to inform ability to complete Trail Making tests A and B. These indicate executive function
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete the MoCA to provide a measure of global cognitive function
Category Fluency (animals)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete Category Fluency to provide a measure of processing speed
Digit Span Backwards (WAIS-IV)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete digit span backwards to provide a measure of executive function
National Institute of Health Computerised Toolbox (NIHCTB)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete the NIHCTB to provide measures of global function
Letter Fluency (FAS)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete the FAS to provide measures of executive function
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4
As part of the neuropsychological battery, participants will complete the RAVLT to provide measures of learning and memory
Brain MRI scan (total scan time 60 mins)- includes T1 weighted imaging
Time frame: Baseline, Year 3
To assess brain morphology
Brain MRI scan (total scan time 60 mins)- includes T2-weighted fluid attenuated inversion recovery (FLAIR) imaging
Time frame: Baseline, Year 3
Combined with T1 outcome to assess brain morphology
Brain MRI scan (total scan time 60 mins)- includes susceptibility-weighted MRI
Time frame: Baseline, Year 3
Assesses cerebral microbleeds. Signal magnitude will be processed to estimate signal decay time (i.e., T2* maps), which reflect compartmentalisation of magnetised tissue constituents (iron, calcium) [22]. Signal phase will be processed for quantitative susceptibility mapping.
Brain MRI scan (total scan time 60 mins)- includes multi-shell diffusion weighted MRI
Time frame: Baseline, Year 3
Measures of brain white matter microstructural integrity, such as fractional anisotropy and mean diffusivity, will be calculated using tensor models. Fixel-based analyses of fibre density and cross-section will also be performed. Markers of cerebrovascular diseases derived from diffusion data, such as Peak width of Skeletonised Mean Diffusivity (PSMD), will be calculated. Structural connectivity will also be examined.
Brain MRI scan (total scan time 60 mins)- includes pseudo-continuous arterial spin labelling (PCASL) perfusion imaging with multiple post-labelling delays.
Time frame: Baseline, Year 3
Used to assess quantitative cerebral blood flow and arterial transit time.
Brain MRI scan (total scan time 60 mins)- includes resting-state blood oxygenation level dependent (BOLD) imaging.
Time frame: Baseline, Year 3
Used to assess brain functional activity and amplitude of low-frequency fluctuations which embeds signal of cerebrovascular reactivity. For sites with available capnography monitors, participants' end-tidal carbon dioxide concentrations will be recorded during acquiring resting-state BOLD data for more accurate quantification of cerebrovascular reactivity
23 secondary outcomes
Blood biochemistry
Time frame: Baseline, Year 3
Ocular Questionnaire
Time frame: Baseline, Year 3
Genetic Profile
Time frame: Baseline
Instrumental Activities of Daily Living Scale (IADL)
Time frame: Baseline
Quality of Life Scale (EQ-5D-5L)
Time frame: Baseline
STOP-BANG Sleep Questionnaire
Time frame: Baseline
PROMIS Sleep Disturbance
Time frame: Baseline
Apathy Evaluation Scale (AES)
Time frame: Baseline
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Study Partner Apathy Evaluation Scale (AES)
Time frame: Baseline
Study Partner Instrumental Activities of Daily Living Scale (IADL)
Time frame: Baseline
Neuropsychiatric Inventory (NPI-Q)
Time frame: Baseline
Blood Omic investigation
Time frame: Baseline and year 3
Ocular Assessment-Visual Acuity
Time frame: Baseline and year 3
Ocular Assessment- Contrast Sensitivity
Time frame: Baseline and year 3
Ocular Assessment- Stereopsis
Time frame: Baseline and year 3
Ocular Assessment- Slit-lamp examination
Time frame: Baseline and year 3
Ocular Assessment- Standard automated perimetry
Time frame: Baseline and year 3
Ocular Assessment- Intraocular pressure
Time frame: Baseline and year 3
Ocular Assessment- Fundus imaging (requires pupil dilation using tropicamide 0.5 or 1.0% eye drops
Time frame: Baseline and year 3
Ocular Assessment- Optical Coherence Tomography (OCT) and OCT-Angiography
Time frame: Baseline and year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cadasil
RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
RecruitingObservational study
Natural History Study of CADASIL
Cardiovascular Disease, Arterial Stiffness
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The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
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Florida Cerebrovascular Disease Biorepository and Genomics Center
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Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Perminder S Sachdev, MBBS, MD, PhD, FRANZCP, FAAHMS principal investigator
University of New South Wales
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cadasil, run by Perminder Sachdev at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danit Saks, MBMSc, MRes, PhD (9348 1658 ext. +612, d.saks@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online Medical Questionnaire (time frame: Baseline, Year 1, Year 2, Year 3, Year 4). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.