Last updated: July 11, 2023
Sponsor: Promomed, LLC
Overall Status: Completed
Phase
4
Condition
Covid-19
Dementia
Mild Cognitive Impairment
Treatment
Placebo
Ethyl methyl hydroxypyridine succinate + Meldonium
Structural and functional MRI
Clinical Study ID
NCT05939622
BRAINMAX_2022
Ages 25-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients able to sign the patient informed consent form for the participation in theclinical study
- Patients of both sexes of 25-50 years of age
- Patient's negative test result for severe acute respiratory syndrome (SARS) -CoV-2 RNAobtained by polymerase chain reaction (PCR) method within 72 hours
- COVID-19 diagnosis documented in the history more than 12 weeks ago*
- Symptoms of Post-COVID-19 syndrome (asthenic state, feeling of energy loss anddecreased functioning, intellectual function disorder, attention and memory disorder,emotional lability, reducing stress resistance) which appeared during or afterCOVID-19, retain for more than 12 weeks and cannot be explained by an alternativediagnosis
- Patients capable of following the requirements of the Clinical Study Protocol
- Negative pregnancy test result (for women with the active childbearing potential)
- MFI-20 scale score is more than 30 at the moment of screening.
- Higher education.
- Lack of decompensated somatic pathology
- Lack of indications of the transferred/current disease of the nervous system
Exclusion
Exclusion Criteria:
- Allergic reactions to the components of the study product
- Taking prohibited drugs/dietary supplements during the previous randomization of themonth
- Severe hepatic failure
- Severe renal failure
- Chronic liver and hepatic diseases
- Thyroid diseases
- Anaemia
- Malignant tumour of any localization currently or during 5 years before the inclusioninto the study except for completely treated carcinoma in situ
- Autoimmune diseases
- Other chronical diseases which, according to the investigator, can cause asthenia
- Pregnancy or lactation period
- Tuberculosis, cancers or positive reaction to the HIV infection, hepatitis B & C,syphilis according to the history data
- Severe eyesight and/or hearing disorders, serious articulation disorders and/or otherdeviations able to prevent the patient from adequate cooperation during the study)
- Mental disorders in the history
- Alcohol, drug abuse or drug dependence in the history
- Patients which, according to the investigator, are obviously or probably incapable ofunderstanding and evaluating this study information within the process of the informedconsent form signing, including but not limited to with regard to expected risks andpossible discomfort
- Other diseases, symptoms or conditions not listed above, which, according to theinvestigator, are predicaments for the participation in the clinical study
- The presence of contraindications for MRI
- The presence of contraindications for taking the drug Contraindications for MRI:
- Electronic medical devices in the body (cardiomyostimulator and other)
- Metal elements in the study area (prosthesis, clamp, fragment)
- Invariable behavior of patients
- Inability to remain still during MRI Prohibited drugs/dietary supplements:
- Ethyl methyl hydroxypyridine succinate and Meldonium (other than the one studied inthe study)
- Psychotropic medication
- Drugs containing succinic acid and its salts
- Drugs containing vitamin B6 and /or its derivatives
- Antioxidants, antihypoxic drug and metabolic drugs
- Nootropic drugs
Study Design
Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 4
Study Start date:
May 18, 2022
Estimated Completion Date:
December 20, 2022
Study Description
Connect with a study center
Federal State Budgetary Research Institution "Research Centre of Neurology"
Moscow,
Russian FederationSite Not Available
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