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

Vascular Dementia Clinical Trial

— VascDem  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947531
• Other study ID #: EBE-RU-051201
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: August 2007

Study information

• Verified date: February 2024
• Source: Ever Neuro Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• Cerebrolysin

• 0.9% Saline Solution

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Ever Neuro Pharma GmbH	acromion GmbH, Geny Research Corp.

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and week 24
Primary	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).	week 24
Secondary	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.	week 4, 12, 16
Secondary	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.	week 4, 12, 16, 24
Secondary	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+.	week 4, 12, 16, 24
Secondary	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.	week 4, 12, 16
Secondary	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.	week 4, 12, 16, 24
Secondary	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.	week 24
Secondary	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.	week 4, 12, 16, 24
Secondary	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.	week 4, 12, 16, 24
Secondary	Change From Baseline in Trail-making Test	The Trail-making test is a frequently used instrument for the assessment of executive function.	week 4, 12, 16, 24
Secondary	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.	week 4, 12, 16, 24
Secondary	Combined Response, i.e. Response in ADAS-COG+ and CIBIC+		week 4, 12, 16, 24