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

Ever Neuro Pharma GmbH242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

242

Conditions

Vascular Dementia

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (21)

Chita State Medical Academy/Regional Psychiatric Hospital No. 2

Chita, Russia

Chita State Medical Academy/Veterans Hospital

Chita, Russia

Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital

Irkutsk, Russia

Kazan State Medical University/Municipal Clinical Hospital No. 6

Kazan', Russia

Kazan State Medical University/Republican Clinical Hospital

Kazan', Russia

Kursk Medical University/Kursk Regional Clinical Hospital

Kursk, Russia

I. M. Sechenov Moscow Medical Academy

Moscow, Russia

Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15

Moscow, Russia

Mental Health Research Center of RAMS

Moscow, Russia

Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital

Moscow, Russia

...and 11 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: week 24

Secondary Outcomes

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.

Time frame: 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.