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CONIVAD

CompletedPhase 2

Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment

Pilot Study on the Association Choline Alphoscerate-Nimodipine in Patients With Subcortical Vascular Cognitive Impairment

Asset

Choline alfoscerate

Listed sites

1

Recruiting sites

-

Enrollment

62

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

Age ≥65MRI 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

Org study ID2015-003188-13
NCT IDNCT03228498

Timeline

Milestones

Study start2017-05-02actual
Study first posted2017-07-25actual
Primary completion2019-07-09actual
Study completion2019-07-09actual
Last update posted2020-01-13actual

Assets

Drug assets

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

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

Executive function / language
3
Global cognition
1
Memory
1
Function / daily living
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Primary/protocol endpoint

Cognitive decline evaluated by the change of MoCA test score compared with Baseline

Time frame:12 months

Montreal Cognitive Assessment (MoCA)

descriptive

Memory

1 endpoint
Secondary/protocol endpoint

Evaluation of memory

Time frame:12 months

descriptive

Executive function / language

3 endpoints
Secondary/protocol endpoint

Evaluation of selective attention

Time frame:12 months

descriptive

Secondary/protocol endpoint

Evaluation of divided attention

Time frame:12 months

descriptive

Secondary/protocol endpoint

Evaluation of maintained attention

Time frame:12 months

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Assessment of functional status

Time frame:12 months

categorical status, descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Evaluation of depressive symptoms

Time frame:12 months

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Assessment of quality of life

Time frame:12 months

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Assessment 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.