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Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment (CONIVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228498
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
MDM S.p.A.
Information provided by (Responsible Party):
Leonardo Pantoni, Azienda Ospedaliero-Universitaria Careggi

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 in reducing cognitive decline in patients with subcortical vascular cognitive impairment

Condition or disease Intervention/treatment Phase
Vascular Cognitive Impairment Drug: Choline alphoscerate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study on the Association Choline Alphoscerate-Nimodipine in Patients With Subcortical Vascular Cognitive Impairment
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : July 9, 2019
Actual Study Completion Date : July 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Choline alphoscerate

Drug: Choline alphoscerate 1200 mg per day and Nimodipine 90 mg per day

concomitant administration

Drug: Choline alphoscerate
Choline alphoscerate 600 mg b.i.d plus Nimodipine 30 mg t.i.d
Other Name: Delecit

Placebo Comparator: Placebo

Placebo and Drug: Nimodipine 90 mg per day only

concomitant administration

Drug: Placebo
Placebo b.i.d plus Nimodipine 30 mg t.i.d




Primary Outcome Measures :
  1. Cognitive decline evaluated by the change of MoCA test score compared with Baseline [ Time Frame: 12 months ]
    Cognitive decline: expressed as the loss of at least 2 points on Montreal Cognitive Assessment (MoCA) test


Secondary Outcome Measures :
  1. Evaluation of selective attention [ Time Frame: 12 months ]
    Selective attention assessed by means of Color Word Stroop Test (CWST)

  2. Evaluation of divided attention [ Time Frame: 12 months ]
    Divided attention assessed by means of Trail Making Test (TMT)

  3. Evaluation of maintained attention [ Time Frame: 12 months ]
    Maintained attention assessed by means of Symbol Digit Modalities Test (SDMT)

  4. Evaluation of memory [ Time Frame: 12 months ]
    Memory assessed by means of Rey Auditory-Verbal Learning Test (RAVLT)

  5. Assessment of functional status [ Time Frame: 12 months ]
    Functional status measured by Disability Assessment for Dementia scale (DAD)

  6. Evaluation of depressive symptoms [ Time Frame: 12 months ]
    Depressive symptoms assessed by means of Center for Epidemiological Studies Depression scale (CES-D)

  7. Assessment of quality of life [ Time Frame: 12 months ]
    Quality of life assessed by means of Stroke-Adapted Sickness Impact Profile (SA-SIP30)

  8. Assessment of drugs' safety and tolerability. [ Time Frame: 12 months ]
    Evaluation of drugs' side effects incidence between two groups of treatment



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228498


Locations
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Italy
Stroke Unit, VAS-COG clinic, Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
MDM S.p.A.
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leonardo Pantoni, Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03228498    
Other Study ID Numbers: 2015-003188-13
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents