Status:
COMPLETED
Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Collaborating Sponsors:
MDM S.p.A.
Conditions:
Vascular Cognitive Impairment
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess whether the combination of choline alphoscerate 1200mg per day and nimodipine 90mg per day given orally is more effective than the combination nimodipine placebo...
Detailed Description
Cerebrovascular diseases represent the second most common cause of dementia after Alzheimer's disease. Since cerebrovascular diseases are age-related, an increase in the incidence of this pathology, d...
Eligibility Criteria
Inclusion
- Cognitive impairment from mild to moderate degree defined by a Clinical Deterioration Rating (CDR) score range between 0.5 and 2.0.
- 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).
- Consent to participation in the study.
Exclusion
- Absence of objectionable cognitive impairment or presence of dementia of severe degree defined by CDR score \> 2.0.
- Unavailability of brain MRI (in case of absolute contraindications, the use of cranial CT is allowed).
- Expected poor compliance with the study protocol.
- Past diagnosis of major depression, schizophrenia, major anxiety syndrome, or manic- depressive illness.
- 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 National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria, Parkinson disease, Huntington disease, frontotemporal dementia).
- 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).
- Medical conditions expected to progress, recur, or change to such a degree to interfere with the assessment of the clinical and mental status.
- Clinically relevant cardiac or pulmonary insufficiency.
- Relevant electrocardiograph abnormalities; bradycardia (50 bpm) or tachycardia (120 bpm) under resting conditions.
- Myocardial infarction within the past 6 months.
- Stroke still requiring neurological rehabilitation.
- Severe/untreated blood pressure (systolic 180 mm Hg, diastolic 95 mm Hg).
- Clinically relevant liver function impairment.
- Insulin-dependent diabetes mellitus.
- Idiopathic epilepsy and anti-epileptic treatment.
- Severe anemia (Hb \<10 mg/dL).
- Severe gastrointestinal disease.
- Cancer.
- Known intolerance to study drugs.
- Coexistent serious illnesses that would imply a drop-out before the end of the trial.
Key Trial Info
Start Date :
May 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03228498
Start Date
May 2 2017
End Date
July 9 2019
Last Update
January 13 2020
Active Locations (1)
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1
Stroke Unit, VAS-COG clinic, Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134