Chemistry:Cerebrolysin
Cerebrolysin (developmental code name FPF-1070) is an experimental mixture of enzymatically-treated peptides derived from pig brain whose constituents can include brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), and ciliary neurotrophic factor (CNTF).[1][2] Although it is under preliminary study for its potential to treat various brain diseases, it is used as a therapy in dozens of countries in Eurasia.
Cerebrolysin has been studied for potential treatment of several neurodegenerative diseases, with only preliminary research, as of 2023.[2] No clear benefit in the treatment of acute stroke has been found, and an increased rate of spontaneous adverse effects requiring hospitalization is reported.[2] Some positive effects have been reported when cerebrolysin is used to treat vascular dementia.[3]
Research
Stroke
A 2023 review indicated that cerebrolysin or cerebrolysin-like peptide mixtures from cattle brain likely provide no benefit for preventing all-cause death in acute ischemic stroke, and that higher quality studies are needed.[2] In addition, cerebrolysin might cause a higher rate of spontaneous adverse events requiring hospitalization.[2]
Studies of ischemic stroke in Asian subpopulations found an absence of benefit.[4] A 2020 study suggested a lack of benefit in hemorrhagic stroke related to cerebral aneurysm.[5]
Dementia
Reviews of preliminary research indicate a possible improvement in cognitive function using cerebrolysin for vascular dementia and Alzheimer's disease, although further high-quality research is needed.[3][6]
Other
Early studies have suggested potential use of cerebrolysin with a wide variety of neurodegenerative disorders, including traumatic brain injury,[7][8] schizophrenia,[9] multiple sclerosis,[10] cerebral palsy[11] and spinal cord injury[12][13] although research is still preliminary.
Adverse effects
Upon injection, adverse effects of cerebrolysin include nausea, dizziness, headache, and sweating.[14] It is not recommended for use in people with epilepsy, kidney disease, or hypersensitivity to the compound constituents.[14]
In trials studying the use of cerebrolysin after acute stroke, there was no increased risk of "serious adverse events" requiring hospitalization.[2] These were specifically defined as "...any untoward medical occurrence that, at any dose, resulted in death, [was] life-threatening, required inpatient hospitalisation or resulted in prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, [was] a congenital anomaly/birth defect, or [was] a medically important event or reaction".[2]
Pharmacology
Laboratory studies indicate there may be neurotrophic effects of cerebrolysin similar to endogenous mechanisms, although its specific molecular effects are not clear.[15]
Cerebrolysin is given by injection.[14] Some of the peptides in cerebrolysin are short-lived once in the blood (for example, the half-life of BDNF is only 10 minutes).[16]
Regulatory
Although cerebrolysin is used in Russia, Eastern European countries, China, and other Asian countries, its status as a government-approved drug is unclear.[2] It is only available by prescription from a physician.[14] According to the manufacturer, the European Medicines Agency has declared cerebrolysin as safe.[14]
As of October 2020, cerebrolysin was not an approved drug in the United States.[17][18]
References
- ↑ "Neurotrophic activities and therapeutic experience with a brain derived peptide preparation". Ageing and Dementia. Journal of Neural Transmission. Supplementa. 53. 1998. pp. 289–98. doi:10.1007/978-3-7091-6467-9_25. ISBN 978-3-211-83114-4. https://link.springer.com/chapter/10.1007/978-3-7091-6467-9_25.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "Cerebrolysin for acute ischaemic stroke". The Cochrane Database of Systematic Reviews 2023 (10). October 2023. doi:10.1002/14651858.CD007026.pub7. PMID 37818733.
- ↑ 3.0 3.1 "Cerebrolysin for vascular dementia". The Cochrane Database of Systematic Reviews 2019 (11). November 2019. doi:10.1002/14651858.CD008900.pub3. PMID 31710397.
- ↑ "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial". Stroke 43 (3): 630–636. March 2012. doi:10.1161/STROKEAHA.111.628537. PMID 22282884.
- ↑ "Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage". BMC Neurology 20 (1). November 2020. doi:10.1186/s12883-020-01908-9. PMID 33143640.
- ↑ "The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review". Journal of Alzheimer's Disease 85 (3): 1195–1204. 2022. doi:10.3233/JAD-215423. PMID 34924395.
- ↑ "Effects of cerebrolysin on functional outcome of patients with traumatic brain injury: a systematic review and meta-analysis". Neuropsychiatric Disease and Treatment 15: 127–135. 2019. doi:10.2147/NDT.S186865. PMID 30643411.
- ↑ "A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury". Neurosurgical Review 41 (2): 427–438. April 2018. doi:10.1007/s10143-016-0775-y. PMID 27539610.
- ↑ "Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms". The Australian and New Zealand Journal of Psychiatry 46 (2): 153–160. February 2012. doi:10.1177/0004867411433213. PMID 22311531.
- ↑ "[Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression]". Zhurnal Nevrologii I Psikhiatrii imeni S.S. Korsakova 116 (12): 48–53. 2016. doi:10.17116/jnevro201611612148-53. PMID 28139626.
- ↑ "Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial". Acta Neurologica Belgica 117 (2): 501–505. June 2017. doi:10.1007/s13760-016-0743-x. PMID 28074392.
- ↑ "Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study". The Spine Journal 18 (7): 1136–1142. July 2018. doi:10.1016/j.spinee.2017.11.002. PMID 29155000.
- ↑ "Cerebrolysin, a mixture of neurotrophic factors induces marked neuroprotection in spinal cord injury following intoxication of engineered nanoparticles from metals". CNS & Neurological Disorders Drug Targets 11 (1): 40–49. February 2012. doi:10.2174/187152712799960781. PMID 22229324.
- ↑ 14.0 14.1 14.2 14.3 14.4 Cite error: Invalid
<ref>tag; no text was provided for refs namedever - ↑ "Cerebrolysin: a review of its use in dementia". Drugs & Aging 26 (11): 893–915. 2009. doi:10.2165/11203320-000000000-00000. PMID 19848437.
- ↑ "Therapeutic potential of brain-derived neurotrophic factor (BDNF) and a small molecular mimics of BDNF for traumatic brain injury". Neural Regeneration Research 12 (1): 7–12. January 2017. doi:10.4103/1673-5374.198964. PMID 28250730.
- ↑ "Nicholasville compounding pharmacy, owner plead guilty to distribution". ABC 36 News. 29 October 2020. https://www.wtvq.com/2020/10/29/nicholasville-compounding-pharmacy-owner-plead-guilty-to-distribution/.
- ↑ (in en) Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs. 24 February 2021. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-sentenced-unlawful-distribution.
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