Alzheimers disease (AD)
Conditions
Interventions
Treatment group:Donepezil hydrochloride tablets combined with Qiaobuxinshen decoction orally, twice daily.
Control Group:Donepezil Hydrochloride Tablets orally, 5 mg every evening before bedtime, then increased to 10 mg after 4 weeks.
Sponsors
Jilin Province Academy of Traditional Chinese Medicine First Clinical Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meets the core clinical criteria for probable AD dementia according to NIA-AA (2011). 2. Age between 65 and 85 years (inclusive of 65 and 85), with no restriction on gender. 3. Clinical Dementia Rating Scale - Global Score (CDR-GS) total score of 2 points. 4. Mini-Mental State Examination (MMSE) score between 11 and 20 points. 5. PES-D-11 subscale score for kidney deficiency and marrow depletion =7. 6. Skull MRI coronal MTA-scale score =1.5 points (age-adjusted values: =1.5 points for 65-74 years, =2.0 points for 75-84 years). 7. The patient has sufficient vision and hearing to participate in clinical assessments, has normal swallowing function, and is able to complete medication intake.
Exclusion criteria
Exclusion criteria: 1. Early-onset (onset before 65 years of age) and mild to severe AD dementia; 2. Non-AD dementia; 3. Presence of unstable mental disorders; 4. History of heavy alcohol consumption or substance abuse within the past 5 years; 5. Other uncontrolled systemic diseases; 6. Severe abnormalities in liver or kidney function; 7. Regular use of cognitive-enhancing drugs within the past month; 8. Use of concomitant medications prohibited in this clinical study; 9. Unable to complete MRI examinations; 10. Intolerance or allergy to the study drug; 11. Currently participating in other studies; 12. Participants deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating Scale (CDR Scale);Mini-Mental State Examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activities of Daily Living Scale;Dementia Symptom Elements Scale; | — |
Countries
China
Contacts
Public ContactXiang Ke
Jilin Province Academy of Traditional Chinese Medicine First Clinical Hospital
Outcome results
None listed