Skip to content

Trial · Interventional

Active, not recruitingPhase 2Registry data

CERebrolysin In CADASIL

Short name CERICA

NCTNCT05755997 (opens ClinicalTrials.gov in a new tab)Other idEVER-CZ-0421Other id2022-002394-29
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
30 participants (estimated)
Sponsor
Ever Neuro Pharma GmbH · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Czechia

Start
29 Nov 2023
Primary completion
31 Mar 2026 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
6 Mar 2023
Last update posted
25 Feb 2025
Conditions
Cadasil

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 2

    CERICA

    NCT05755997

    29 Nov 2023 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CerebrolysinDrug
  • 0.9 % NaClDrug

Arms2

  • Other

    Study group 1

    Cerebrolysin - Placebo

  • Other

    Study group 2

    Placebo - Cerebrolysin

Primary outcomes10

Outcomes the sponsor listed as primary.

  1. Change in cognitive battery (RAVLT)

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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- Trail Making Test (Part B)

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

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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- Montreal Cognitive Assessment (MoCA)

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

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

    Registry description

    \- Beck Depression Inventory-II (BDI-II)

  10. Change in imaging (White matter lesion volume)

    Time frame · Baseline, Month 12, Month 27

    Registry description

    \- White matter lesion volume (MRI)

Secondary outcomes(11)

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

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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- 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

    Registry description

    \- Beck Anxiety Inventory

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

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

    Registry description

    \- NIH stroke scale (NIHSS)

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

    Time frame · Baseline, Month 12, Month 27

    Registry description

    \- Index of general cortical thinning (MRI)

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

    Time frame · Baseline, Month 12, Month 27

    Registry description

    \- Post-stroke lacune volume (MRI)

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

    Time frame · Baseline, Month 12, Month 27

    Registry description

    \- Neurofilament light chain (NFL)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients of ≥18 years of age, all genders 2. Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis 3. MoCA \>11 4. Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures 5. Patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception) 6. Patient participates voluntarily and gave written informed consent Exclusion Criteria: 1. Any significant neurological disease/conditions other than CADASIL 2. Focal lesions that may be responsible for the cognitive status of the patient (e.g. infectious disease, space-occupying lesion, normal pressure hydrocephalus) 3. Any other diseases/conditions that may affect compliance with the protocol, such as: 1. severe psychiatric disorders within the last three months 2. delusional symptoms 3. history of schizophrenia, schizoaffective disorder, bipolar affective disorder 4. major depressive disorder newly identified within eight weeks before screening 5. history of alcohol or substance abuse or dependence within the past two years 4. 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 5. Any other disease/conditions that may affect the safety assessment, such as: 1. history of systemic cancer within the past two years 2. 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) 3. any clinically significant laboratory abnormalities at screening 4. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c \>87 mmol/mol) 6. Use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam) 7. Any condition that would represent a contraindication for Cerebrolysin administration: 1. hypersensitivity to one of the components of the drug 2. epilepsy 3. severe renal impairment (estimated Glomerular Filtration Rate \[eGFR\] \<30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)

PepBank is a research reference. Talk to a doctor before you use any peptide.