Adrenomedullin for CADASIL (NCT06072118) | Clinical Trial Compass
CompletedPhase 2
Adrenomedullin for CADASIL
Japan60 participantsStarted 2022-01-06
Plain-language summary
Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is the most common form of hereditary cerebral small vessel disease, with no proven disease-modifying treatments. Adrenomedullin, a vasoactive peptide, has angiogenic, vasodilation, anti-inflammatory, and anti-oxidative properties and could have triple sites of action on components of the neuro-glial-vascular unit consisting of vessels, microglia and oligodendrocytes or, more specifically, on the white matter oligovascular unit. The aim of the AMCAD trial is to assess the safety and efficacy of Adrenomedullin in CADASIL patients.
Who can participate
Age range20 Years ā 90 Years
SexALL
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Inclusion criteria
ā. Patients who have given written informed consent from the patient or the sponsor to participate in the clinical trial
ā. Patients aged between 20 and 90 at the time of obtaining consent
ā. Patients diagnosed as CADASIL after confirming NOTCH3 gene mutation by genetic testing
ā. Patients with Mini-mental state examination-J score of 10-27 or Trail maiking test score (age ajustment) of average + 1.5 SD (standard deviation) or higher
Exclusion criteria
ā. Patients who cannot perform cognitive function tests (deafness, blindness, etc., MMSE-J less than 10 points Severe cognitive impairment, etc.)
ā. Patients received reatment with prohibited drugs or prohibited therapy within the past 12 weeks from the time of registration
ā. Patients who started to take concomitant restriction drugs or changed dosage of concomitant restriction drugs within the past 4 weeks from the time of registration
ā. Patients whose Mini-mental state examination-J with 4 or more points improvements between the time of registration and 4 weeks or more at the time of screening (If patients who take concomitant restriction drugs)
What they're measuring
1
Cerebral blood flow change rate evaluated by arterial spin labeling
Timeframe: at 28 days post adrenomedullin administration
Trial details
NCT IDNCT06072118
SponsorNational Cerebral and Cardiovascular Center, Japan