Mild cognitive impairment
Conditions
Interventions
Treatment group:Compound Congrong Yizhi Capsules 0.3 g per capsule 4 capsules orally three times daily
Sponsors
Hospital of Chengdu University of TCM
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with mild cognitive impairment (MCI) by a psychiatrist or neurologist from a tertiary Grade A hospital meeting the following criteria: a. MCI due to Alzheimers disease (AD-MCI) per the 2011 National Institute on Aging-Alzheimers Association (NIA-AA) criteria; b. Vascular MCI (VaMCI) per the 2014 Vas-Cog criteria; c. Modified Hachinski Ischemic Scale (MHIS) total score =4; d. MCI confirmed by: • Subjective memory complaints lasting >6 months; • Montreal Cognitive Assessment (MoCA) Chinese version score below age/education-adjusted cutoff; • Activities of Daily Living (ADL) score =18; • Exclusion of dementia psychiatric disorders brain injury or other neuropsychiatric disabilities. (2) TCM syndrome of Liver and Kidney Deficiency Syndrome with Phlegm-Stasis Obstructing Collaterals. (3) Age 40–85 years gender unrestricted. (4) Minimum 1 year of formal education intact auditory/visual function and ability to comply with assessments and treatment. (5) Voluntary participation with informed consent form signed by the patient or legal representative.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of dementia. (2) Received TCM medications Western medications or acupuncture targeting cognitive function within the past 1 month. (3) Structural brain abnormalities causing cognitive impairment (e.g. traumatic brain injury intracranial space-occupying lesions) or congenital mental retardation. (4) Presence of delirium depression or other neurological/psychiatric disorders. (5) Alcohol or drug dependence within the past 6 months or currently per DSM-II-R (Diagnostic and Statistical Manual of Mental Disorders 2nd Edition Revised) criteria. (6) Pregnant or breastfeeding women. (7) Severe diseases of vital organs (heart liver kidney lungs) or multiple organ failure. (8) History of hypersensitivity or contraindications to the study drug or its components. (9) Currently participating in other clinical trials. (10) Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Digit Symbol Substitution Test;Clinician's Interview-Based Impression of Change plus caregiver input;Diagnostic Imaging;TCM Syndrome Assessment Scale;Alzheimers Disease Assessment Scale-Cognitive subscale;Clinical Dementia Rating;Montreal Cognitive Assessment;Activities of Daily Living;Neuropsychiatric Inventory;Verbal Fluency Test;Digit Span Test;Neurofilament Protein; | — |
Countries
China
Contacts
Public ContactYang Dongdong
Hospital of Chengdu University of TCM
Outcome results
None listed