Alzheimer's disease
Conditions
Interventions
Group1 (Healthy control group):No drug intervention
Group2 (aMCI drug therapy group):Huicong Granules + Donepezil
Group3 (aMCI control group):Donepezil
Group4 (AD mild to moderate dementia drug treatment group):Huicong Granules + Donepezil
Group 5 (AD mild to moderate dementia control group):Donepezil
Sponsors
Liaoning University of Chinese Medicine/ the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. CN group (cognition normal) (1) Age: 55 - 85 years old (inclusive); Have a primary school education or above and be able to complete relevant cognitive tests and other rating scales; (2) Meet the diagnostic criteria of CN group; (3) MMSE: 27 < MMSE <= 30 min; (4) Sign the informed consent voluntarily as the subject. 2. aMCI (Syndrome of deficiency of Qi and Yin, phlegm turbidity and stasis) (1) Age: 55 - 85 years old (inclusive); Have a primary school education or above and be able to complete relevant cognitive tests and other rating scales; (2) Meeting the diagnostic criteria of aMCI group; (3) MMSE: 21 <= MMSE <= 27 min; MoCA-B: illiterate, primary school <= 19 points; Secondary school score <= 22, college score <= 24; (4) Cholinesterase inhibitors and amantadine are acceptable if stable at 12 weeks prior to screening; (5) Normal liver and kidney function; (6) Those who meet the criteria for TCM syndrome diagnosis; (7) Sign informed consent voluntarily as the subject. 3. AD mild to moderate dementia (Qi and Yin deficiency, phlegm turbidity-stasis syndrome) (1) Age: 55 - 85 years old (inclusive); Have a primary school education or above and be able to complete relevant cognitive tests and other rating scales; (2) Meet the diagnostic criteria of mild to moderate dementia in AD; (3) MMSE: primary school level <= 20 points, secondary school (including technical secondary school) <= 22 points, university level (including junior college) <= 23 points; Clinical dementia score (CDR) = 1.0 or 2.0; Daily Living Ability Rating Scale (ADL): <= 60 points; (4) Cholinesterase inhibitors and amantadine are acceptable if they are stable at 12 weeks prior to screening; (5) Normal liver and kidney function; (6) Those who meet the criteria for TCM syndrome diagnosis; (7) Sign informed consent voluntarily as the subject.
Exclusion criteria
Exclusion criteria: 1. History of stroke; 2. Other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, neoplasm, encephalitis, and epilepsy; 3. Major depression, Hamilton Rating Scale for Depression (HAMD) score > 24 points; 4. Traumatic brain injury; 5. Systemic diseases, such as thyroid dysfunction, syphilis and HIV; 6. Psychosis or congenital mental retardation; 7. There is visual related organic damage; 8. Severe diseased sinus syndrome; 9. Participants who were unable to complete the neuropsychological assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-related potential;ADAS-cog12; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score; | — |
Countries
China
Contacts
Public ContactZhan Libin
Liaoning University of Liaoning University of Chinese Medicine/ the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed