← Trials/Trial dossier/NCT03228498
CONIVAD
CompletedPhase 2Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment
Pilot Study on the Association Choline Alphoscerate-Nimodipine in Patients With Subcortical Vascular Cognitive Impairment
Lead sponsor
Asset
Choline alfoscerate
Listed sites
1
Recruiting sites
-
Enrollment
62
actual
Study population
Vascular cognitive impairment / dementia
Key I/E criteria
•Age ≥65•MRI contraindications excluded
Primary endpoint
•Montreal Cognitive Assessment (MoCA)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointCognitive decline evaluated by the change of MoCA test score compared with Baseline
Time frame:12 months
Montreal Cognitive Assessment (MoCA)
descriptive
Memory
1 endpointEvaluation of memory
Time frame:12 months
descriptive
Executive function / language
3 endpointsEvaluation of selective attention
Time frame:12 months
descriptive
Evaluation of divided attention
Time frame:12 months
descriptive
Evaluation of maintained attention
Time frame:12 months
descriptive
Function / daily living
1 endpointAssessment of functional status
Time frame:12 months
categorical status, descriptive
Behavior / neuropsychiatric
1 endpointEvaluation of depressive symptoms
Time frame:12 months
descriptive
Caregiver / quality of life
1 endpointAssessment of quality of life
Time frame:12 months
descriptive
Safety / tolerability / PK
1 endpointAssessment of drugs' safety and tolerability.
Time frame:12 months
event count, event
Publications (13)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID1916007via BACKGROUND
- PMID20610345via BACKGROUND
- PMID28476873via BACKGROUND
- PMID33855653via DERIVED
- PMID8937788via BACKGROUND
- PMID15692125via BACKGROUND
- PMID22550606via BACKGROUND
- PMID23867200via BACKGROUND
- PMID31148099via DERIVED
- PMID15537523via BACKGROUND
- PMID15817019via BACKGROUND
- PMID12849265via BACKGROUND
- PMID23602162via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.