A Clinical Trial to Evaluate the Safety and Efficacy of [amount hidden] Cerebrolysin in Patients With Vascular Dementia

What Was Tested

The trial (phase 4) is built around Cerebrolysin.

The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.

It had two arms (groups): Cerebrolysin (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

242 actual participants took part.

It was open to people of any sex aged from 50 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol; patients who in the investigator's opinion, would not comply with study procedures; history of alcohol or substance abuse or dependence within the past two years.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cerebrolysin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-10 with completion listed for 2007-08.

It ran at 21 sites in Russia (21).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 (time frame: baseline and week 24). CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 (time frame: week 24).

It also tracked 11 secondary outcomes, for example Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart), ADAS-COG+ Response, Change From Baseline for Original ADAS-COG, CIBIC+ Score, CIBIC+ Response and CIBIS+ (Clinicians Interview-Based Impression of Severity).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 242 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cerebrolysin compound page, all human trials.