mild cognitive impairment due to Alzheimer's disease
Conditions
Interventions
Shenghui Granules Group:Shenghui Granules
Sponsors
Hubei university of Chinese medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of MCI due to AD; 2. Male or female aged 50-85 (including the threshold) at the time of signing the informed consent form; 3. Right-handedness; 4. The clinical dementia rating scale (CDR) was 0.5; 5. The overall cognitive function is normal: MMSE belongs to the normal range (junior high school and above > 24 points, primary school > 20 points, illiteracy > 17 points); 6. The ability of daily living (ADL) was basically normal; 7. AVLT-H recall delay scale score is less than or equal to the lower limit of the range of the corresponding age group (2 points for 70-85 years old; 3 points for 60-69 years old; 4 points for 50-59 years old); 8. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Combined with serious diseases of the cardiovascular, cerebral, hepatic, renal and hematopoietic systems; 2. Having active epilepsy; 3. History of psychiatric disorders such as depression, anxiety disorders or family history. 4. Excluding cognitive dysfunction caused by other diseases, such as vascular dementia, Lewy body dementia, Parkinson's disease dementia, etc. 5. The presence of severe or unstable other medical conditions that can affect brain function or affect the evaluation of cognitive function. 6. Those with severe neurological deficits that prevent the completion of cognitive function measurements 7. Those with a history of asthma or obstructive pulmonary disease 8. A history of alcohol or psychotropic substance abuse 9. The presence of contraindications to MRI (e.g., pacemakers, cardiac stents, artificial heart valves, fixed plates after fracture surgery, etc.) 10. Patients with a history of allergy to donepezil hydrochloride, piperidine derivatives, or excipients in the formulation. 11. pregnancy. 12. Patients with rare genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 13. Those participating in other clinical trials. 14. Other reasons why the investigator considers it inappropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s disease assessment scale-cognitive score;The Pattern Element Scale for Dementia(PES-D-11); | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment (MoCA);auditory verbal learning test-HuaShan version,AVLT-H;neuropsychiatric inventory(NPI);Alzheimer Disease Cooperative Study-Activity of Daily Living(ADCS-ADL);plasma Aß1-40;plasma Aß1-42;plasma Tau protein;Pittsburgh sleep quality index(PSQI);electroencephalogram;Physical Activity Rating Scale-3(PARS-3);Insomnia Severity Index(ISI);Polysomnography,PSG;Cerebral MR; | — |
Countries
China
Contacts
Public ContactWANG Ping
Hubei university of Chinese medicine
Outcome results
None listed