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OpenTrials
Active, Not Recruiting

NCT Number: NCT05755997

CERebrolysin In CADASIL

The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to Placebo in patients with genetically proven CADASIL. In addition, a traditional approach will be taken based on an evaluation of the separate risk and benefit domains in comparison with placebo.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

CADASIL Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dementia, Vascular Genetic Diseases, Inborn Infarction Intracranial Arterial Diseases Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Motol University Hospital

Prague, 150 06, Czechia

About this study

Safety data area collected throughout the study (adverse events, vital signs and laboratory tests) and thereafter in case of ongoing serious adverse events (SAEs) at study endpoint.

Optional secondary parameters include analyses of biomarkers (samples of blood, hair, urine, and saliva).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of ≥18 years of age, all genders
  • Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis
  • MoCA >11
  • Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures
  • Patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception)
  • Patient participates voluntarily and gave written informed consent

Exclusion criteria

  • Any significant neurological disease/conditions other than CADASIL
  • Focal lesions that may be responsible for the cognitive status of the patient (e.g.

infectious disease, space-occupying lesion, normal pressure hydrocephalus)

  • Any other diseases/conditions that may affect compliance with the protocol, such as:
  • severe psychiatric disorders within the last three months
  • delusional symptoms
  • history of schizophrenia, schizoaffective disorder, bipolar affective disorder
  • major depressive disorder newly identified within eight weeks before screening
  • history of alcohol or substance abuse or dependence within the past two years
  • Any circumstances that -in the investigator's opinion- may result in the patient's non-compliance with study procedures, e.g. fragile or thin veins that prevent many i.v. infusions
  • Any other disease/conditions that may affect the safety assessment, such as:
  • history of systemic cancer within the past two years
  • history of myocardial infarction in the past year or unstable or severe cardiovascular disease (including uncontrolled hypertension and/or history of unstable hypertension not compensated by antihypertensive therapy)
  • any clinically significant laboratory abnormalities at screening
  • uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >87 mmol/mol)
  • Use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam)
  • Any condition that would represent a contraindication for Cerebrolysin administration:
  • hypersensitivity to one of the components of the drug
  • epilepsy
  • severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)

Treatment and study plan

Cerebrolysin

Drug

40 ml Cerebrolysin and 60 ml 0.9% NaCl per day for 4 days every month for 1 year

Other names: Renacenz

0.9 % NaCl

Drug

100 ml 0.9% NaCl per day for 4 days every month for 1 year

Other names: Sodium Chloride

Primary outcomes

  1. Change in cognitive battery (RAVLT)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Rey Auditory Verbal Learning Test (AVLT)

  2. Change in cognitive battery (ROCF: Copy, immediate recall)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Rey-Osterrieth Complex Figure Test (ROCF): Copy, immediate recall

  3. Change in cognitive battery (Digit Symbol Coding, subscale of WAIS-PSI)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Digit Symbol Coding (subscale of WAIS-PSI)

  4. Change in cognitive battery (Digit Span: Digit backward (subscale of WAIS-WMI)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Digit Span: Digit backward (subscale of WAIS-WMI)

  5. Change in cognitive battery (Trail Making Test, Part B)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Trail Making Test (Part B)

  6. Change in cognitive battery (ROCF: Delayed recall)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Rey-Osterrieth Complex Figure Test (ROCF): Delayed recall

  7. Change in cognitive battery (Stroop Color and Word Test - Prague Version)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Stroop Color and Word Test - Prague Version (word/dots interference)

  8. Change in cognitive battery (MoCA)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Montreal Cognitive Assessment (MoCA)

  9. Change in mood (Beck Depression Inventory-II)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Beck Depression Inventory-II (BDI-II)

  10. Change in imaging (White matter lesion volume)

    Time frame: Baseline, Month 12, Month 27

    • White matter lesion volume (MRI)

Secondary outcomes

  1. Change in cognitive battery, secondary outcome (Spatial Pattern Separation Task)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Spatial Pattern Separation Task

  2. Change in cognitive battery, secondary outcome (Navigation Test Suite)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Navigation Test Suite

  3. Change in cognitive battery, secondary outcome (Trail Making Test, Part A)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Trail Making Test (Part A)

  4. Change in cognitive battery, secondary outcome (Stroop Color and Word Test - Prague Version)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Stroop Color and Word Test - Prague Version (color-word/dots interference)

  5. Change in cognitive battery, secondary outcome (Symbol Search, subscale of WAIS-PSI)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Symbol Search (subscale of WAIS-PSI)

  6. Change in cognitive battery, secondary outcome (Digit Span: Digit forward, subscale of WAIS-WMI)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Digit Span: Digit forward (subscale of WAIS-WMI)

  7. Change in mood, secondary outcome (Beck Anxiety Inventory)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • Beck Anxiety Inventory

  8. Change in neurological deficits, secondary outcome (NIH stroke scale)

    Time frame: Baseline, Month 6, Month 12, Month 21, Month 27

    • NIH stroke scale (NIHSS)

  9. Change in imaging, secondary outcome (Index of general cortical thinning)

    Time frame: Baseline, Month 12, Month 27

    • Index of general cortical thinning (MRI)

  10. Change in imaging, secondary outcome (Post-stroke lacune volume)

    Time frame: Baseline, Month 12, Month 27

    • Post-stroke lacune volume (MRI)

  11. Change in biomarker analysis, secondary outcome (Neurofilament light chain)

    Time frame: Baseline, Month 12, Month 27

    • Neurofilament light chain (NFL)

Other outcomes

  1. Experimental (to be defined after study endpoint): Change in Serotonin level (hair, mean)

    Time frame: Baseline, Month 12, Month 27

    • mean over several weeks

  2. Experimental (to be defined after study endpoint): Change in Oxytocin level (hair, mean)

    Time frame: Baseline, Month 12, Month 27

    • mean over several weeks

  3. Experimental (to be defined after study endpoint): Change in Cortisol level (hair, mean)

    Time frame: Baseline, Month 12, Month 27

    • mean over several weeks

  4. Experimental (to be defined after study endpoint): Change in Serotonin level (hair, greyish level)

    Time frame: Baseline, Month 12, Month 27

    • hair color (greyish level)

  5. Experimental (to be defined after study endpoint): Change in Oxytocin level (hair, greyish level)

    Time frame: Baseline, Month 12, Month 27

    • hair color (greyish level)

  6. Experimental (to be defined after study endpoint): Change in Cortisol level (hair, greyish level)

    Time frame: Baseline, Month 12, Month 27

    • hair color (greyish level)

  7. Experimental (to be defined after study endpoint): Change in Serotonin level (saliva, day value)

    Time frame: Baseline, Month 12, Month 27

    • value of this time at this day

  8. Experimental (to be defined after study endpoint): Change in Oxytocin level (saliva, day value)

    Time frame: Baseline, Month 12, Month 27

    • value of this time at this day

  9. Experimental (to be defined after study endpoint): Change in Cortisol level (saliva, day value)

    Time frame: Baseline, Month 12, Month 27

    • value of this time at this day

  10. Experimental (to be defined after study endpoint): Change in Serotonin level (saliva, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  11. Experimental (to be defined after study endpoint): Change in Oxytocin level (saliva, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  12. Experimental (to be defined after study endpoint): Change in Cortisol level (saliva, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  13. Experimental (to be defined after study endpoint): Change in Serotonin level (blood pellet, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  14. Experimental (to be defined after study endpoint): Change in Oxytocin level (blood pellet, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  15. Experimental (to be defined after study endpoint): Change in Cortisol level (blood pellet, epigenetic age)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic age

  16. Experimental (to be defined after study endpoint): Change in Serotonin level (blood pellet, omega-3 fatty acids)

    Time frame: Baseline, Month 12, Month 27

    • omega-3 fatty acids

  17. Experimental (to be defined after study endpoint): Change in Oxytocin level (blood pellet, omega-3 fatty acids)

    Time frame: Baseline, Month 12, Month 27

    • omega-3 fatty acids

  18. Experimental (to be defined after study endpoint): Change in Cortisol level (blood pellet, omega-3 fatty acids)

    Time frame: Baseline, Month 12, Month 27

    • omega-3 fatty acids

  19. Experimental (to be defined after study endpoint): Change in Serotonin level (blood plasma)

    Time frame: Baseline, Month 12, Month 27

    • somascan

  20. Experimental (to be defined after study endpoint): Change in Oxytocin level (blood plasma)

    Time frame: Baseline, Month 12, Month 27

    • somascan

  21. Experimental (to be defined after study endpoint): Change in Cortisol level (blood plasma)

    Time frame: Baseline, Month 12, Month 27

    • somascan

  22. Experimental (to be defined after study endpoint): Change in Serotonin level (urine, alpha klotho)

    Time frame: Baseline, Month 12, Month 27

    • alpha klotho

  23. Experimental (to be defined after study endpoint): Change in Oxytocin level (urine, alpha klotho)

    Time frame: Baseline, Month 12, Month 27

    • alpha klotho

  24. Experimental (to be defined after study endpoint): Change in Cortisol level (urine, alpha klotho)

    Time frame: Baseline, Month 12, Month 27

    • alpha klotho

  25. Experimental (to be defined after study endpoint): Change in Serotonin level (urine, epigenetic markers)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic markers

  26. Experimental (to be defined after study endpoint): Change in Oxytocin level (urine, epigenetic markers)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic markers

  27. Experimental (to be defined after study endpoint): Change in Cortisol level (urine, epigenetic markers)

    Time frame: Baseline, Month 12, Month 27

    • epigenetic markers

  28. Experimental (to be defined after study endpoint): Change in capillary permeability (Ktrans) in grey and white matter

    Time frame: Baseline, Month 12, Month 27

    Capillary permeability (Ktrans) in grey and white matter (MRI)

Sponsors and collaborators

Lead sponsor

Ever Neuro Pharma GmbH

Industry

Collaborators

  • XClinical GmbH
  • idv Datenanalyse & Versuchsplanung

Registry information

Official study title

A Randomized, Double-blind, Single-centre, Two-period Cross-over, Placebo-controlled Trial on Safety and Efficacy in Patients With Genetically Proven CADASIL

Acronym: CERICA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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