None listed
Conditions
Interventions
Drug : Subjects are randomly assigned to receive either 800 mg oral Oxiracetam for 36 weeks or placebo twice a day
Intervention drug: Neuromed 800mg (oxiracetam 800mg)
Comparator: Placebo
Sponsors
KOREAN DRUG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women over 50 2) Patients who have been suffering from stroke for more than three months 3) Patients with subjective cognitive impairment that satisfies the following conditions: - screened through one-question questionnaires - "Do you think you've had a problem with your cognitive function, including memory, since your stroke?" - with at least 7 points in Subjective Cognitive Decline - Questionnaire(SCD-Q) OR with a memory domain of 0.5 or more points in the Clinical Dementia Rating (CDR) 4) high risk for dementia conversion Patients with at least one of the following four items - As of the date of trial registration (visit 1), adults over 70 years of age - Patients with relapse history of stroke - Patients diagnosed with atrial fibrillation or diabetes mellitus - one of the followings in the index-stroke MRI: * moderate to severe white matter hyperintensities (Fazekas grade 2 or more) * moderate to severe cerebral cortical atrophy (Global Cortical Atrophy score, GCA-S, grade 2 or more) * medial temporal lobe atrophy (Schelten's visual grade 2 or more) 5) Patients with a life expectancy of more than 12 months during screening 6) Subject (If applicable, a legitimate representative) who give written consent to voluntarily participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) an academic background below elementary school graduation 2) Patients with a modified Rankin scale (mRS) of 3 or higher at the time of screening test 3) Dementia patients with Global Clinical dementia rating (CDR) of 1 or higher at the time of screening test 4) Patients with cognitive impairment due to diseases other than cerebrovascular (Alzheimer's disease, Parkinson's disease, thyroid disease, vitamin B12 or folic acid deficiency, subdural hematoma, central nervous system infection, Huntington's disease, normal pressure hydrocephalus, etc.) 5) Patients unable to perform walking or continuous physical activity - disabilities in everyday life due to musculoskeletal function disorders or chronic pain (eg , history of hip fracture) - acute and severe respiratory symptoms and diseases (eg, acute and severe asthma) - Patients with severe or unstable cardiovascular diseases (eg, severe heart failure ) 6) Patients who have abnormal liver function test values at the time of screening (ALT, AST levels exceed 3 times the normal upper limit) 7) Patients with severe renal impairment whose creatinine clearance (CrCl) is less than 15 ml / min at the time of screening test 8) Patients with hemoglobin less than 8mg / dL or platelet count less than 50,000 / mm3 at the time of screening test 9) At the time of the screening test, the HbA1c level exceeds 11%, the SBP level exceeds 180 mmHg, or the TSH level exceeds 1.5 times the normal upper limit. 10) Patients who took oxiracetam, acetylcholine esterase inhibitor (galantamine, donepezil, rivastigmine), memantine, choline precursor, acetylcarnitine, piracetam, etc. within one month from the date of clinical trial registration (Visit 1) 11) Patients who are taking medications that may affect the cognitive function specified in Section 6.7.1 of the clinical trial protocol, who cannot maintain a stable dose for at least 30 days before the clinical study registration date (visit 1) and until the end of the clinical trial after registration 12) Patients with severe aphasia, hearing or vision impairment that cannot be evaluated validation study (K-MMSE) 13) Patients with MRI contraindications including pacemakers 14) People with mental illness such as schizophrenia and major depression 15) Patients with alcohol or illegal substance abuse or dependence 16) Patients with hypersensitivity to clinical trial drugs, pyrrolidine derivatives or other additives 17) Patients who participated in another clinical trial within 1 month of screening (The end of the previous clinical trial is set as the last administration date. Observational studies without drugs do not matter, except clinical studies that evaluate cognitive impairment.) 18) Pregnant or lactating women 19) female subjects with childbearing potential during the trial period, who do not agree to contraception in a manner acceptable to the trial protocol * Medically accepted methods of contraception: hormonal contraception , intrauterine device (IUD), intrauterine system (IUS), vasectomy, fallopian tube ligation, double blocking (male condom, female condom, cervical cap), contraceptive diaphragm, multiple use of blocking method such as contraceptive sponge) 20) Patients with severe bleeding, cardiovascular and endocrine diseases that are difficult to perform this study 21) Patients who are judged to be unsuitable to participate in this clinical trial, or may have conditions that may influence the evaluation of the results of this clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Mini-Mental State Examination scores;Changes in Clinical Dementia Rating Sum of Boxes | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in memory domain test scores (Seoul Verbal Learning Test-Elderly version);Changes in frontal domain test (Semantic fluency, Phonemic fluency, Digit Symbol Coding, Korean-Trail Making Test-Elderly’s version A & B);Changes in Korean Instrumental Activities of Daily Living;Changes in Neuropsychiatric inventory;Changes in Euro Quality of Life (EQ index);Changes in z-scores of Frontal Function Score in Korean Vascular Cognitive Impairment Harmonization Standards Neuropsychology Protocol;Changes in z-scores of Global Cognitive Function Score in Korean Vascular Cognitive Impairment Harmonization Standards Neuropsychology Protocol;Changes in Short form of Geriatric Depression Scale;Patient’s Global Assessment;Changes in brain functional network efficiency measures | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Sung Lim
Hallym University Medical Center
Outcome results
None listed