Choline alphoscerate-nimodipine in vascular cognitive impairment

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.
10) Myocardial infarction within the past 6 months.
11) Stroke still requiring neurological rehabilitation.
12) Severe/untreated blood pressure (systolic 180 mm Hg, diastolic 95 mm Hg).
13) Clinically relevant liver function impairment.
14) Insulin-dependent diabetes mellitus.
15) Idiopathic epilepsy and anti-epileptic treatment.
16) Severe anemia (Hb <10 mg/dL).
17) Severe gastrointestinal disease.
18) Cancer.
19) Known intolerance to study drugs.
20) Coexistent serious illnesses that would imply a drop-out before the end of the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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