Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment

• Status: Completed
• Trial end date: 2019-07-09
• Target enrollment: 0
• Participant gender: All

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 in reducing cognitive decline in patients with subcortical vascular cognitive impairment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Collaborator: MDM S.p.A.
• Treatments: Choline; Nimodipine

Criteria

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.

Exclusion Criteria:

1. Absence of objectionable 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 National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association 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.