Cognitive Dysfunction Clinical Trial
Official title:
A Multicentre Double-blind Placebo-controlled Randomized Study of Efficacy and Safety of Cytoflavin®, Intravenous Administration and Enteric-coated Tablets, Used in Elderly Patients for Prevention of Cognitive Decline After Major Surgery
Verified date | January 2023 |
Source | POLYSAN Scientific & Technological Pharmaceutical Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postoperative cognitive impairment develops in the early and continues in the late postoperative period; it is manifested by impaired memory, attention, concentration and other higher cortical functions (thinking, speech). Early studies demonstrated the positive impact of perioperative administration of Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), which prevented impairments of intelligence, speech, and attention after cardiac surgery, both in conditions of cardiopulmonary bypass and on a working heart. The aim of the present study is to evaluate the safety and efficacy of Cytoflavin for the prevention of cognitive disorders after major surgeries performed in elderly patients.
Status | Completed |
Enrollment | 200 |
Est. completion date | July 11, 2019 |
Est. primary completion date | April 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Signed informed consent 2. Men and women aged 60-80 years, inclusive. 3. Planned cardiac surgery, which does not assume the use of a cardiopulmonary bypass. 4. Planned or delayed orthopedic surgery (hip joint endoprosthetics, osteosynthesis for fractures of the proximal third of the hip, etc.), under general or combined anesthesia. 5. Legal capacity of the patient 6. Absence of dementia (MoCA=17, MMSE=19) 7. Lack of reproductive potential or 8. Consent to use adequate methods of contraception Exclusion Criteria: 1. Hypersensitivity to any component of the study drug 2. Emergency surgery 3. Repeated surgery or reoperation 4. Anesthesia risk ASA=5 5. Severe visual or hearing impairment which impedes the performance of neuropsychological tests 6. Operation under general anesthesia in the previous 3 months 7. Severe renal failure requiring replacement of renal function (dialysis) 8. Severe hepatic failure (class C and above in Child-Pugh) 9. Chronic obstructive pulmonary disease 10. Terminal stage of other chronic incurable diseases 11. Decompensated diabetes 12. A history of oncological diseases, mental illness, HIV infection, syphilis, tuberculosis, alcohol or drug addiction 13. The use of 5 or more units of alcohol per week in the previous 3 months 14. Diagnosis of mental or neurodegenerative disease (e.g. schizophrenia, Parkinson's disease, clinically manifest depression) 15. Permanent intake of psychotropic drugs (neuroleptics, tranquilizers, antidepressants) 16. Course intake of nootropic drugs in the previous 3 months 17. Communicative, sensory, motor, or any other deficiency that does not allow the patient to adequately assess their behavior and correctly fulfill the conditions of the study protocol. 18. The presence in the history of any significant, according to the physician-researcher, condition that prevents the inclusion of the patient in the study. 19. Participation in any clinical study in the previous 3 months 20. Employees of the study centres and their family members. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Regional Clinical Hospital ? 3 | Chelyabinsk | |
Russian Federation | Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation | Moscow | |
Russian Federation | Alexandrovskaya City Hospital | Saint Petersburg | |
Russian Federation | City Hospital ?15 | Saint Petersburg | |
Russian Federation | City Hospital ?38 named after N.A. Semashko | Saint Petersburg | |
Russian Federation | City Hospital ?40 of the Kurortny District | Saint Petersburg | |
Russian Federation | Hospital for War Veterans | Saint Petersburg | |
Russian Federation | I. P. Pavlov 1st St. Petersburg State Medical University | Saint Petersburg | |
Russian Federation | Military Medical Academy named after S.M. Kirov | Saint Petersburg | |
Russian Federation | Pokrovskaya City Hospital | Saint Petersburg | |
Russian Federation | GBUZ YAO "Regional Clinical Hospital" | Yaroslavl | |
Russian Federation | Research center of specialized types of medical care "Ural Institute of Cardiology" | Yekaterinburg | |
Russian Federation | Ural State Medical University | Yekaterinburg |
Lead Sponsor | Collaborator |
---|---|
POLYSAN Scientific & Technological Pharmaceutical Company |
Russian Federation,
Kovalenko A.L., Nagibovich O.A., Vishnevsky A.Yu., Belekhov G.A., Gubaidullin R.R., Popov D.V., Agafiina A.S. Use of a Neurometabolism-Targeting Drug in Prevention of Postoperative Cognitive Dysfunction. General Reanimatology. 2022;18(2):12-21. https://doi.org/10.15360/1813-9779-2022-2-12-21
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montreal Cognitive Assessment (MoCA) scale score | The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change in the MoCA scale score by the end of the treatment course compared with the preoperative score. | 32 days | |
Secondary | The Mini-Mental State Examination (MMSE) scale | MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the treatment course compared to the preoperative score | 32 days | |
Secondary | The Mini-Mental State Examination (MMSE) follow-up score | MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the follow-up period | 90 days | |
Secondary | Montreal Cognitive Assessment (MoCA) follow-up | The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change of the MoCA scale score by the end of the follow-up period | 90 days | |
Secondary | Median group Mini-Mental State Examination (MMSE) score | MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the difference between median group total scores on the MMSE scale. | day 7, 32, 90 | |
Secondary | Median Montreal Cognitive Assessment (MoCA) scale score | The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the difference in median group values of the MOCA scale | day 7, 32, 90 | |
Secondary | Proportion of postoperative delirium | The proportion of patients who developed postoperative delirium in the first 96 hours after surgery according to the results of CAM-ICU | day 3-6 | |
Secondary | Length of stay in the ICU | Length of stay in the ICU | day 32 | |
Secondary | Mortality | Mortality in the postoperative period in the experimental and control groups | day 32 | |
Secondary | Postoperative cognitive decline | The proportion of patients with a decrease in the results of two or more neuropsychological tests by more than 20% by the end of the treatment course and by the end of the follow-up period compared the baseline values | day 32, day 90 | |
Secondary | Quality of life score | Change in the overall score for the EQ-5D questionnaire for assessing the quality of life | day 90 | |
Secondary | Independence and activity | The proportion of patients dependent in at least two daily functions according to the results of the Katz Daily Activity Index at the end of the treatment course | day 32 | |
Secondary | Anxiety/depression | The group average score by Hospital Anxiety and Depression Scale (HADS) at the end of the treatment course and at the end of the follow-up period. The HADS is a fourteen item scale, a person can score between 0 and 21 for either anxiety or depression, where scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21). | day 32, day 90 |
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