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CadasilPhase 2CERICANCT05755997

CERebrolysin In CADASIL

A Phase 2 study testing Cerebrolysin and 0.9 % NaCl in people with Cadasil, run by Ever Neuro Pharma GmbH at 1 site in Czechia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cadasil
What is being tested?
Cerebrolysin and 0.9 % NaCl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCzechia
Study dates
29 Nov 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Motol University Hospital

    Prague, 150 06

Other trials in Czechia

About this study

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

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).

Conditions
Cadasil
Being tested
Cerebrolysin, 0.9 % NaCl
Medical subject headings
CADASIL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CerebrolysinDrug

    Also called Renacenz

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

  • 0.9 % NaClDrug

    Also called Sodium Chloride

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

Study groups in NCT05755997
Study groupRoleWhat they receive
Study group 1OtherCerebrolysin - Placebo
Receives: Drug: Cerebrolysin; Drug: 0.9 % NaCl
Study group 2OtherPlacebo - Cerebrolysin
Receives: Drug: Cerebrolysin; Drug: 0.9 % NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognitive battery (RAVLT)

    • Rey Auditory Verbal Learning Test (AVLT)

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

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

    • Trail Making Test (Part B)

    Measured: 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

    Measured: 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)

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

  8. Change in cognitive battery (MoCA)

    • Montreal Cognitive Assessment (MoCA)

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

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

    • Beck Depression Inventory-II (BDI-II)

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

  10. Change in imaging (White matter lesion volume)

    • White matter lesion volume (MRI)

    Measured: Baseline, Month 12, Month 27

Secondary outcomes (11)

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

    • Spatial Pattern Separation Task

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

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

    • Navigation Test Suite

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

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

    • Beck Anxiety Inventory

    Measured: Baseline, Month 6, Month 12, Month 21, Month 27

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

    • NIH stroke scale (NIHSS)

    Measured: 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)

    Measured: Baseline, Month 12, Month 27

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

    • Post-stroke lacune volume (MRI)

    Measured: Baseline, Month 12, Month 27

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

    • Neurofilament light chain (NFL)

    Measured: Baseline, Month 12, Month 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start29 Nov 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A two-period cross-over design, in which participants will be randomly allocated to either the Verum-Control sequence (sequence 1) or the Control-Verum sequence (sequence 2) in a 1:1 randomization.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755997
Sponsor's protocol ID
EVER-CZ-0421
Other IDs
2022-002394-29
Acronym
CERICA
Status last verified
Feb 2025
First submitted
14 Feb 2023
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cerebrolysin and 0.9 % NaCl in people with Cadasil, run by Ever Neuro Pharma GmbH at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive battery (RAVLT) (time frame: Baseline, Month 6, Month 12, Month 21, Month 27). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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