GCT has truly extensive experience in CNS field. The table below reflects some experience examples we have had in the area. We effectively managed numerous trials in Alzheimer’s disease, Multiple Sclerosis, and Epilepsy in our regions. GCT’s core staff and top-management have Neurology and Psychiatry background which helps us maintain strong and solid relationships with KOLs and high-recruiting investigative sites.
| Phase | # Pnts | # Sites | Countries | Indication | Sponsor |
|---|---|---|---|---|---|
| II | 80 | 5 | Bulgaria | Alzheimer's Disease | Global Biotech |
| II | 54 | 7 | Russia | Alzheimer's Disease | US Pharma |
| IIb | 148 | 19 | Bulgaria, Russia | Epilepsy | US Pharma |
| II | 222 | 22 | Russia | Multiple Sclerosis | US Biopharma |
| III | 150 | 28 | Russia, Ukraine | Schizophrenia | US Pharma |
| III | 90 | 9 | Bulgaria, Ukraine | Alzheimer's Disease | Global Biotech |
| I | 20 | 1 | Russia | Multiple Sclerosis | EU Pharma |
| II | 250 | 21 | Russia, Ukraine | Alzheimer's Disease | Global Biotech |
| III | 75 | 19 | Bulgaria, Russia | Epilepsy | US Pharma |
| Device | 150 | 8 | Romania | Acute Ischemic Stroke | Israeli Medical Device Company |
Below is the figure demonstrating the Projection vs Actual enrollment for a recent Alzheimer study conducted by GCT:
The incidence of epilepsy is 3.4 per 1000 in Russia. It is one of the four most frequent infant diseases (7 cases per 1000 children). As per infant diseases, the problem of child psychoneurology is a burning issue. 83% of children in Russia have neurological symptoms and signs. In the country, 7-28% of children suffer from attention deficit hyperactivity disorder (ADHD). Stroke is the second most common “killer” of people worldwide. Every year in Russia some 450,000 people suffer from stroke, a figure comparable to the population of a city like Atlanta, GE. Mortality of the Russian population from cerebrovascular disease is 4 times higher than in the U.S. and Canada and has the highest rate among European countries. According to the All-Russian Center for Preventive Medicine, in our country cerebrovascular diseases kill 25% of all men and 39% of women.
Age-standardized disability-adjusted life year rates from cerebrovascular disease by country (per 100,000 inhabitants) collected by World Health Organization.
According to the recent report of the Association of Oncologists of Russia, the CNS tumor rate is 4.08 per 100,000. Incidence of brain tumors in the country is 3.7 per 100,000. CNS tumors in children rank second place in malignant neoplasms after leucosis, and account for 18% of all infant oncological diseases. Most CNS clinical studies – amounting to several hundred – in Russia have been conducted in MS, epilepsy, AD, stroke, depression and schizophrenia; however, the potential of the region in terms of a pool of treatment-naive patients and a number of sites to contribute to international clinical research is huge.
Dementia observed in more than 10 million people in the EU today, which makes it one of the most serious health problems in the 21st century. The current population of Russia is around 147 million people. As per latest statistics approximately 40% of them suffer from various types of mental illnesses, and more than 20 million need psychological help. More than 900,000 people have schizophrenia and 250-300,000 have manic state. The Russian market is still looking for new effective medications and state-of-art diagnostics in the Alzheimer’s disease and Multiple sclerosis areas. Currently 1.3 million Russians have dementia and 150,000 have MS. Annually there are 3.160 million of first time diagnosed patients with neurosis, depression, AD, MS, etc.
More information
We will be happy to provide more information about CNS studies in CEE and Russia. Please contact us or simply use the form below. A representative will respond shortly.
