Alzheimer‘s Disease
Conditions
Interventions
Regulating Heart and Kidney Formula Group:Regulating Heart and Kidney Formula
Sponsors
Shanghai Geriatric Institute of Chinese Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Alzheimer's disease according to the core clinical criteria for Alzheimer's-type dementia established by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2011, with a Clinical Dementia Rating (CDR) scale score between 0.5 and 1 (0.5 < CDR = 1). 2. Diagnosed with the pattern of Heart and Kidney Deficiency according to traditional Chinese medicine (TCM) syndrome differentiation. 3. Aged between 60 and 80 years old (60 = age < 80), regardless of gender.
Exclusion criteria
Exclusion criteria: 1. Any other neurological diseases causing dementia, including Parkinson's disease, epilepsy, brain trauma, tumors, infections, poisoning, etc.; 2. A history of depression within the past 2 years or other mental disorders that meet the diagnostic criteria of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); 3. A history of alcohol or drug abuse or dependence within the past 2 years; 4. Any apparent systemic disease or unstable medical condition; 5. Use of drugs affecting brain function within 2 weeks prior to screening; 6. Blood routine: white blood cells = 10×10^9/L or < 4×10^9/L, red blood cells < 4×10^12/L, platelets < 100×10^9/L, hemoglobin < 100g/L; kidney function test: creatinine = 120µmol/L; liver function test: alanine aminotransferase (ALT) = 60IU/L, aspartate aminotransferase (AST) = 40IU/L, ?-glutamyltransferase (?-GGT) = 60IU/L."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog); | — |
Secondary
| Measure | Time frame |
|---|---|
| Five Zang-organs Deficiency Syndrome of Traditional Chinese Medicine;Multimodal Cognitive Function Assessment;MMSE, CDR, ADL; | — |
Countries
China
Contacts
Public ContactWu Beilingling
Shanghai Geriatric Institute of Chinese Medicine
Outcome results
None listed