Amnestic mild cognitive impairment
Conditions
Interventions
Integrated traditional Chinese and western medicine group:1) Sodium Oligomannate Capsules: 450mg, po, bid
2) Yangxue Qingnao Pills: 2 packs, administered after being dissolved in water, po, bid
3) sham cognitive training: remote computer-assisted cognitive training task, 40 min/day, 4 days/week.
Sodium Oligomannate Capsules group:1) Sodium Oligomannate Capsules: 450mg, po, bid
2) placebos of Yangxue Qingnao Pills: 2 packs, administered after being dissolved in water, po, bid
3) sham cognitive training: sham cognitive training task, 40 min/day, 4 days/week.
Control group:1) placebos of Sodium Oligomannate Capsules: 2 capsules, po, bid
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 = 80 years; 2. Patients with amnestic mild cognitive impairment (aMCI) due to AD in accordance with the clinical criteria for diagnosis of mild cognitive impairment (MCI) developed by National Institute on Aging (NIA) and Alzheimers Association (AA) in 2011; 3. Neuropsychological evaluation in accordance with the normal scores (> 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. Subjects diagnosed with dementia at baseline; 2. Subjects with a clear history of cerebrovascular stroke and clear symptoms or signs of neurological deficits at the time of the onset, and the neuroimaging has the corresponding responsible lesions; 3. Brain MRI indicating serious cerebral white matter lesion (Fazekas score of = 3); 4. Subjects with disturbance in consciousness from any cause; 5. Subjects with serious aphasia or extremity disability who are unable to complete the neuropsychological test; 6. Subjects currently having relevant depressive disorders (Hamilton Depression Rating Scale score of > 8) or psychiatric disorders such as schizophrenia; 7. Subjects with toxic metabolic disorders (e.g., hepatic or renal insufficiency, endocrine disease, vitamin deficiency, history of alcohol poisoning, or history of drug addiction) that may cause mild cognitive impairment; 8. Subjects with brain infarction, head trauma, epilepsy, encephalitis, normal pressure hydrocephaly, and other nervous system disorders that may cause cognitive impairment; 9. Abnormal laboratory outcomes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (liver function) greater than 2 times the upper limit of normal (ULN), creatinine (Cr) (renal function) greater than 2 times the ULN, creatine kinase greater than 2 times the ULN, white blood cell count < 4.0 × 109 or platelets < 100 × 109, haemoglobin < 100 g/L, random blood glucose value greater than 1.2 times the ULN; 10. Female subjects with a positive pregnancy test or who are breastfeeding and subjects who are unable to take effective contraception measures or are planning to have a child; 11. Subjects who are participating in another drug clinical study; 12. Subjects who took the drugs that have an impact on cognitive function within 1 month before the initiation of this study, such as cholinesterase inhibitors, memantine, cholinomimetic drugs, antipsychotics, anxiolytics, hypnotics, and nootropic drugs (including traditional Chinese herbal medicine and pills, such as Congrong Yizhi capsule and Jian Nao An); 13. Subjects who were treated with Sodium Oligomannate Capsules or Yangxue Qingnao Pills within 6 months before screening; 14. Subjects with a history of allergy or adverse reactions to Yangxue Qingnao Pills and Sodium Oligomannate Capsules; 15. Subjects who are unable to undergo the imaging examination of brain MRI; 16. Subjects who are not suitable for participation in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment (MoCA) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| CDR score;a battery of neuropsychological testing (auditory verbal learning test, number connection test, digit span test and word fluency test) score;Mini-mental State Examination (MMSE) score;Pittsburgh Sleep Quality Index (PSQI) score;Imaging outcomes;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactYifeng Du
Outcome results
None listed