Vascular DementiaPhase 4VascDemNCT00947531

A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

A Phase 4 study testing Cerebrolysin and 0.9% Saline Solution in people with Vascular Dementia, run by Ever Neuro Pharma GmbH at 21 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Vascular Dementia
What is being tested?: Cerebrolysin and 0.9% Saline Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 242 participants
Where: 21 sitesRussia
Study dates: Oct 2006to Aug 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or post-menopausal women between 50 and 85 years
Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
CT or MRI results compatible with clinical diagnosis
MMSE score between 10 and 24, both inclusive
Modified Hachinski Ischemic Score >4
Hamilton Depression Scale score of less than or equal to 15
Adequate visual and auditory acuity to allow neuropsychological testing
Informed consent given by the patient and/or the next-of-kin

Who cannot join

Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
Any severe systemic illness or unstable medical condition that could lead to difficulty complying with the protocol or significantly limits life span.
Patients who in the investigator's opinion, would not comply with study procedures
Any significant neurological disease other than vascular dementia, such as Parkinson's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
History of alcohol or substance abuse or dependence within the past two years

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Patients with a history of systemic cancer within the past two years
Severe congestive heart failure or malignant, uncontrollable hypertension
Participation in a clinical trial with an investigational drug in the past four weeks

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Russia21 sites

Chita State Medical Academy/Regional Psychiatric Hospital No. 2
Chita
Chita State Medical Academy/Veterans Hospital
Chita
Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
Irkutsk
Kazan State Medical University/Municipal Clinical Hospital No. 6
Kazan'
Kazan State Medical University/Republican Clinical Hospital
Kazan'
Kursk Medical University/Kursk Regional Clinical Hospital
Kursk
I. M. Sechenov Moscow Medical Academy
Moscow
Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15
Moscow
Mental Health Research Center of RAMS
Moscow
Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital
Moscow
Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1
Moscow
Scientific Research Institute of Neurology of RAMS
Moscow
Municipal Clinical Hospital No. 5
Nizhny Novgorod
N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital
Nizhny Novgorod
Central Municipal Hospital
Reutov
I. P. Pavlov St. Petersburg State Medical University
Saint Petersburg
S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF
Saint Petersburg
V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute
Saint Petersburg
Saratov Regional Psychiatric Hospital of Snt. Sofia
Saratov
Bashkirian State Medical University/Emergency Medical Care Hospital
Ufa
Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8
Yaroslavl

Other trials in Russia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV [intravenous] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.

Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.

Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.

Conditions: Vascular Dementia
Being tested: Cerebrolysin, 0.9% Saline Solution
Medical subject headings: Dementia, Vascular

What participants receive

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

CerebrolysinDrug
0.9% Saline SolutionDrug

Study groups in NCT00947531
Study group	Role	What they receive
Cerebrolysin	Experimental	Not described Receives: Drug: Cerebrolysin
0.9% Saline Solution	Placebo comparator	Not described Receives: Drug: 0.9% Saline Solution

What is being measured

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

Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
Measured: baseline and week 24
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).
Measured: week 24

Secondary outcomes (11)

Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)
The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.
Measured: week 4, 12, 16
ADAS-COG+ Response
A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.
Measured: week 4, 12, 16, 24
Change From Baseline for Original ADAS-COG
The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.
Measured: week 4, 12, 16, 24
CIBIC+ Score
The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.
Measured: week 4, 12, 16
CIBIC+ Response
A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.
Measured: week 4, 12, 16, 24
CIBIS+ (Clinicians Interview-Based Impression of Severity)
The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.
Measured: week 24
Change From Baseline in MMSE (Mini-Mental State Examination) Score
The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language.
Measured: week 4, 12, 16, 24
Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.
Measured: week 4, 12, 16, 24
Change From Baseline in Trail-making Test
The Trail-making test is a frequently used instrument for the assessment of executive function.
Measured: week 4, 12, 16, 24
Change From Baseline in Clock-drawing Test
The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.
Measured: week 4, 12, 16, 24
Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Measured: week 4, 12, 16, 24

Timeline

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

Oct 2006Aug 2007

First posted28 Jul 2009 (estimated)
Study startOct 2006
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vascular DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00947531
Sponsor's protocol ID: EBE-RU-051201
Acronym: VascDem
Status last verified: Feb 2024
First submitted: 20 Apr 2009
Last updated: 21 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Guekht AB, Moessler H, Novak PH, Gusev EI; Cerebrolysin Investigators. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):310-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.012. Epub 2010 Jul 24.
PubMed 20656516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
ClinicalTrials.gov ID: NCT00947531
Acronym / sponsor ID: VascDem / EBE-RU-051201
Conditions: Vascular Dementia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
Collaborators: acromion GmbH, Geny Research Corp.
Study start: Oct 2006
Study completion: Aug 2007 (actual)
First posted: 28 Jul 2009 (estimated)
Results: Posted 28 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cerebrolysin	Experimental	Drug: Cerebrolysin
0.9% Saline Solution	Placebo comparator	Drug: 0.9% Saline Solution

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men or post-menopausal women between 50 and 85 years
Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
CT or MRI results compatible with clinical diagnosis
MMSE score between 10 and 24, both inclusive
Modified Hachinski Ischemic Score >4

Key exclusion criteria (9 listed)

Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
Any severe systemic illness or unstable medical condition that could lead to difficulty complying with the protocol or significantly limits life span.
Patients who in the investigator's opinion, would not comply with study procedures
Any significant neurological disease other than vascular dementia, such as Parkinson's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cerebrolysin	Drug	Cerebrolysin
0.9% Saline Solution	Drug	0.9% Saline Solution

Primary outcome

Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
Time frame: baseline and week 24
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
Time frame: week 24
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).

11 secondary outcomes

Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)
Time frame: week 4, 12, 16
ADAS-COG+ Response
Time frame: week 4, 12, 16, 24
Change From Baseline for Original ADAS-COG
Time frame: week 4, 12, 16, 24
CIBIC+ Score
Time frame: week 4, 12, 16
CIBIC+ Response
Time frame: week 4, 12, 16, 24
CIBIS+ (Clinicians Interview-Based Impression of Severity)
Time frame: week 24
Change From Baseline in MMSE (Mini-Mental State Examination) Score
Time frame: week 4, 12, 16, 24
Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
Time frame: week 4, 12, 16, 24
Change From Baseline in Trail-making Test
Time frame: week 4, 12, 16, 24
Change From Baseline in Clock-drawing Test
Time frame: week 4, 12, 16, 24
Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Time frame: week 4, 12, 16, 24

Results and safety

Results posted to the registry on 28 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cerebrolysin	121	107
0.9% Saline Solution	121	110

Primary outcome: Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24

Time frame: baseline and week 24. Mean (Standard Deviation). Unit: points on a scale

Measure	Cerebrolysin n = 117	0.9% Saline Solution n = 115
Value	-10.60 (7.77)	-4.49 (8.13)

Cerebrolysin vs 0.9% Saline Solution: Mean Difference (Final Values): -6.17 (95% CI -8.22 to -4.13), p < 0.0001, ANCOVA

Population analysed: The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.

Primary outcome: CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24

Time frame: week 24. Count of participants. Unit: Participants

Measure	Cerebrolysin n = 117	0.9% Saline Solution n = 115
Marked improvement	7	2
Moderate improvement	43	14
Minimal improvement	38	27
No change	20	52
Minimal worsening	9	16
Moderate worsening	0	4
Marked worsening	0	0

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cerebrolysin	3 of ?	0 of 117 (0%)	Not reported
0.9% Saline Solution	0 of ?	0 of 115 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20656516Guekht AB, Moessler H, Novak PH, Gusev EI; Cerebrolysin Investigators. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):310-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.012. Epub 2010 Jul 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philipp Novak, PhD study director

EBEWE Neuro Pharma

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cerebrolysin and 0.9% Saline Solution in people with Vascular Dementia, run by Ever Neuro Pharma GmbH at 21 sites in Russia.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Russia. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 (time frame: baseline and week 24). The study lists 2 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 NCT00947531, which also lists 1 linked publication.

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 21 Feb 2024.