Pilot study on the association choline alphoscerate-nimodipine in patients with subcortical vascular cognitive impairment - CONIVAD

AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI0 sites60 target enrollmentFebruary 17, 2022

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2022

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Cognitive impairment from mild to moderate degree defined by a Clinical Deterioration Rating (CDR) score range between 0\.5 and 2\.0\.
•2\) Evidence on brain MRI of white matter hyperintensities (leukoaraiosis of moderate or severe degree according to the modified Fazekas visual scale and/or presence of lacunar infarcts).
•3\) Consent to participation in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 60

•1\) Absence of objectivizable cognitive impairment or presence of dementia of severe degree defined by CDR score \> 2\.0\.
•2\) Unavailability of brain MRI (in case of absolute contraindications, the use of cranial CT is allowed).
•3\) Expected poor compliance with the study protocol.
•4\) Past diagnosis of major depression,
•schizophrenia, major anxiety syndrome, or manic\- depressive illness.
•5\) Diagnosis of degenerative cognitive impairment based on clinical and/or neuroradiological findings (i.e., patients with prevailing memory impairment, or with medial temporal atrophy on brain MRI in absence of evident vascular abnormalities; i.e., Alzheimer disease as defined using the NINCDS/ADRDA criteria, Parkinson disease, Huntington disease, frontotemporal dementia).
•6\) Diagnosis of cognitive impairment from other causes (i.e., vitamine B12 and folic acid deficiency, thyroid disorders, metabolic diseases, head trauma, tumor or infections of the central nervous system, normal pressure hydrocephalus).
•7\) Medical conditions expected to progress, recur, or change to such a degree to interfere with the assessment of the clinical and mental status.
•8\) Clinically relevant cardiac or pulmonary insufficiency.
•9\) Relevant electrocardiograph abnormalities; bradycardia (50 bpm) or tachycardia (120 bpm) under resting conditions.