ClinicalTrials.gg
Sign In
Active, not recruitingNCT05755997CERICAUpdated Feb 25, 2025

CERebrolysin in CADASIL

A Phase 2 interventional study of Cerebrolysin and 0.9 % NaCl in Cadasil, sponsored by Ever Neuro Pharma GmbH. Active, not recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Ever Neuro Pharma GmbH · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Cadasil

Browse trials for

03

In context

CADASIL

33 studies on the registry are indexed under CADASIL; 18 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 10 interventional studies indexed under CADASIL.

Browse CADASIL studies →

Lead sponsor

Ever Neuro Pharma GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients of ≥18 years of age, all genders
  2. Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis
  3. >11
  4. Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures
  5. Patient is not of (i.e. women are for two years, surgically sterile, or using adequate method of )
  6. Patient participates voluntarily and gave written

Exclusion criteria

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 laboratory abnormalities at screening
    4. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus ( >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 for Cerebrolysin administration:

    1. to one of the components of the drug
    2. epilepsy
    3. severe renal impairment (estimated [eGFR] \<30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Study group 1

    Cerebrolysin - Placebo

    Drug: Cerebrolysin · Drug: 0.9 % NaCl

  • Other
    Study group 2

    Placebo - Cerebrolysin

    Drug: Cerebrolysin · Drug: 0.9 % NaCl

Interventions

  • DrugCerebrolysin

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

    Also known as: Renacenz

  • Drug0.9 % NaCl

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

    Also known as: Sodium Chloride

06

What researchers measure

Primary outcomes

  1. Change in cognitive battery (RAVLT)

    - Rey Auditory Verbal Learning Test (AVLT)

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

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

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

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

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

    - Digit Symbol Coding (subscale of WAIS-PSI)

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

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

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

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

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

    - Trail Making Test (Part B)

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

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

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

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

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

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

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

  8. Change in cognitive battery (MoCA)

    - Montreal Cognitive Assessment (MoCA)

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

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

    - Beck Depression Inventory-II (BDI-II)

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

  10. Change in imaging (White matter lesion volume)

    - White matter lesion volume (MRI)

    Time frame: Baseline, Month 12, Month 27

Secondary outcomes

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

    - Spatial Pattern Separation Task

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

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

    - Navigation Test Suite

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

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

    - Trail Making Test (Part A)

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

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

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

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

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

    - Symbol Search (subscale of WAIS-PSI)

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

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

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

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

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

    - Beck Anxiety Inventory

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

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

    - NIH stroke scale (NIHSS)

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

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

    - Index of general cortical thinning (MRI)

    Time frame: Baseline, Month 12, Month 27

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

    - Post-stroke lacune volume (MRI)

    Time frame: Baseline, Month 12, Month 27

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

    - Neurofilament light chain (NFL)

    Time frame: Baseline, Month 12, Month 27

Other outcomes

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

    - mean over several weeks

    Time frame: Baseline, Month 12, Month 27

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

    - mean over several weeks

    Time frame: Baseline, Month 12, Month 27

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

    - mean over several weeks

    Time frame: Baseline, Month 12, Month 27

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

    - hair color (greyish level)

    Time frame: Baseline, Month 12, Month 27

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

    - hair color (greyish level)

    Time frame: Baseline, Month 12, Month 27

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

    - hair color (greyish level)

    Time frame: Baseline, Month 12, Month 27

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

    - value of this time at this day

    Time frame: Baseline, Month 12, Month 27

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

    - value of this time at this day

    Time frame: Baseline, Month 12, Month 27

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

    - value of this time at this day

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic age

    Time frame: Baseline, Month 12, Month 27

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

    - omega-3 fatty acids

    Time frame: Baseline, Month 12, Month 27

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

    - omega-3 fatty acids

    Time frame: Baseline, Month 12, Month 27

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

    - omega-3 fatty acids

    Time frame: Baseline, Month 12, Month 27

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

    - somascan

    Time frame: Baseline, Month 12, Month 27

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

    - somascan

    Time frame: Baseline, Month 12, Month 27

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

    - somascan

    Time frame: Baseline, Month 12, Month 27

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

    - alpha klotho

    Time frame: Baseline, Month 12, Month 27

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

    - alpha klotho

    Time frame: Baseline, Month 12, Month 27

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

    - alpha klotho

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic markers

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic markers

    Time frame: Baseline, Month 12, Month 27

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

    - epigenetic markers

    Time frame: Baseline, Month 12, Month 27

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

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

    Time frame: Baseline, Month 12, Month 27

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05755997
Lead sponsor
Ever Neuro Pharma GmbH
Collaborators
idv Datenanalyse & Versuchsplanung, XClinical GmbH
Responsible party
Sponsor
First posted
Mar 6, 2023
Start date
Nov 29, 2023
Primary completion
Mar 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 25, 2025

Study contacts

Aleš Tomek, MUDr., Ph.D.
principal investigator · Motol University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Cerebrolysin

Other studies in this condition

CADASIL →

Other studies from this sponsor

Ever Neuro Pharma GmbH

Start the discussion