Amnestic mild cognitive impairment
Conditions
Interventions
Control group:(1) Mannat Sodium Capsules placebo: 2 capsules, po, bid
(2) Yangxuenao pills placebo: 2 packets, washed with water, po, bid
(3) Sham cognitive training: sham cognitive training task , 40 minutes of training a day, 4 days a week.
Sodium Oligomannate Capsules group:(1) Mannat sodium capsules: 450mg, po, bid
(2) Yangxuenao pills placebo: 2 packets, taken with water, po, bid
(3) Sham cognitive training: sham cognitive training task, one day training 40 minutes of training 4 days a week.
Integrated traditional Chinese and western medicine group:(1) Mannat sodium capsule: 450mg, po, bid
(2) Yangxuenao pills: 2 packs, taken with water, po, bid
(3) Cognitive training: remote computer-assisted cognitive training task, 40 training sessions per day minutes, training 4 days a week.
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with an age of >= 50 and 20 for subjects whose education attainment is elementary school or lower and > 24 for subjects whose education attainment is middle school or higher) for Mini-Mental State Exam (MMSE), Clinical Dementia Rating (CDR) score of 0.5 (memory = 0.5 or 1), and Activities of Daily Living (ADL) score of <= 23; 4. Subjects who are able to communicate skillfully in Chinese (not illiterate); 5. Subjects with a stable and reliable caregiver who can accompany the subject to attend study visits to provide valuable information on the CDR score and assist the investigator in the diagnosis of cognitive impairment; 6. Subjects who are able to operate computer independently or under the guidance of the caregiver; 7. Subjects who are able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is a clear history of cerebrovascular stroke, and there are clear symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left on neuroimaging; 2. Severe white matter lesions (Fazekas score >= 3); 3. Suffering from any disorder of consciousness; 4. Those with physical disabilities who cannot complete the neuropsychological examination; 5. Those who currently suffer from related depression (score of Hamilton Depression Scale>8) or schizophrenia and other mental diseases; 6. Those with a history of alcoholism, drug addiction, or neurological diseases that can cause cognitive impairment such as traumatic brain injury, epilepsy, encephalitis, normal intracranial pressure hydrocephalus; 7. Have systemic diseases that may lead to mild cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiencies); 8. Abnormal laboratory indicators: liver function (ALT, AST) exceeds 2 times the upper limit of the normal range, renal function (Cr) exceeds 2 times the upper limit of the normal range, creatine kinase exceeds 2 times the upper limit of the normal range, and white blood cell count < 4.0 x 10 ^9 or platelets <100x10^9, hemoglobin <100g/L, random blood glucose value exceeding 1.2 times the upper limit of the normal range; 9. Female subjects with positive pregnancy test or breastfeeding and subjects who are unable to take effective contraceptive measures or have childbearing plans; 10. Participating in other drug clinical investigators; 11. Use of drugs that affect cognitive function within 1 month before the start of this study, such as: cholinesterase inhibitors, memantine, cholinergic drugs, antipsychotics, anxiolytics, hypnotics, nootropics (including traditional Chinese herbs and pills, such as Cistanche Yizhi Capsule, Jiannaoan, etc.); 12. Patients who have received Mannat Sodium Capsules and Yangxuenao Pills within 6 months before screening; 13. Those who are allergic to Yangxue Nao Pill and Mannat Sodium Capsule or have a history of adverse reactions; 14. Those who are unable to perform head MRI imaging examination; 15. The investigators believe that they are not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment (MoCA) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-mental State Examination (MMSE) score;a battery of neuropsychological testing (auditory verbal learning test, number connection test, digit span test and word fluency test) score;Clinical Dementia Rating Scale (CDR) score;Pittsburgh Sleep Quality Index (PSQI) score;TCM syndrome score;Imaging outcomes; | — |
Countries
China
Contacts
Public ContactDu Yifeng
Shandong Provincial Hospital
Outcome results
None listed