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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name VascDem

NCTNCT00947531 (opens ClinicalTrials.gov in a new tab)Other idEBE-RU-051201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
242 participants (actual)
Sponsor
Ever Neuro Pharma GmbH · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Russia

Start
Oct 2006
Primary completion
Not stated
Completion
Aug 2007
First posted
28 Jul 2009 (estimated)
Last update posted
21 Feb 2024
Conditions
Vascular Dementia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 4

    VascDem

    NCT00947531

    Oct 2006 to Aug 2007

Registry summary

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

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.

Interventions

  • CerebrolysinDrug
  • 0.9% Saline SolutionDrug

Arms2

  • Experimental

    Cerebrolysin

  • Placebo comparator

    0.9% Saline Solution

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · baseline and week 24

    Registry description

    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.

  2. CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24

    Time frame · week 24

    Registry description

    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).

Secondary outcomes(11)

  1. Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)

    Time frame · week 4, 12, 16

    Registry description

    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.

  2. ADAS-COG+ Response

    Time frame · week 4, 12, 16, 24

    Registry description

    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.

  3. Change From Baseline for Original ADAS-COG

    Time frame · week 4, 12, 16, 24

    Registry description

    The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.

  4. CIBIC+ Score

    Time frame · week 4, 12, 16

    Registry description

    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.

  5. CIBIC+ Response

    Time frame · week 4, 12, 16, 24

    Registry description

    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.

  6. CIBIS+ (Clinicians Interview-Based Impression of Severity)

    Time frame · week 24

    Registry description

    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.

  7. Change From Baseline in MMSE (Mini-Mental State Examination) Score

    Time frame · week 4, 12, 16, 24

    Registry description

    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.

  8. Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)

    Time frame · week 4, 12, 16, 24

    Registry description

    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.

  9. Change From Baseline in Trail-making Test

    Time frame · week 4, 12, 16, 24

    Registry description

    The Trail-making test is a frequently used instrument for the assessment of executive function.

  10. Change From Baseline in Clock-drawing Test

    Time frame · week 4, 12, 16, 24

    Registry description

    The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.

  11. Combined Response, i.e. Response in ADAS-COG+ and CIBIC+

    Time frame · week 4, 12, 16, 24

Posted results

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

Primary outcome results

Primary outcomeMean· baseline and week 24

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

GroupValue (points on a scale)Spread
Cerebrolysin-10.607.77
0.9% Saline Solution-4.498.13
Primary outcomeCount of participants· week 24

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

GroupValue (Participants)
Cerebrolysin7
0.9% Saline Solution2
Secondary and other outcome results(6)
Secondary outcome· week 4, 12, 16

Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)

GroupValue
Secondary outcome· week 4, 12, 16, 24

ADAS-COG+ Response

GroupValue
Secondary outcome· week 4, 12, 16, 24

Change From Baseline for Original ADAS-COG

GroupValue
Secondary outcome· week 4, 12, 16

CIBIC+ Score

GroupValue
Secondary outcome· week 4, 12, 16, 24

CIBIC+ Response

GroupValue
Secondary outcome· week 24

CIBIS+ (Clinicians Interview-Based Impression of Severity)

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cerebrolysin–3 / ?0 / 117
0.9% Saline Solution–0 / ?0 / 115

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

6 results

Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

Guekht et al. 2011Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Associationcited by 36

PMID 20656516DOI 10.1016/j.jstrokecerebrovasdis.2010.01.012PUB-20656516

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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