Alzheimer's Disease
Conditions
Interventions
Experimental Group:Compound Cistanche Intellecti-boosting Capsules 0.3g per capsule, 4 capsules each time, orally, 3 times daily
Control Group:Donepezil Hydrochloride Tablets, Oral, 5 mg per dose, once daily.
Sponsors
Tongde Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the core clinical criteria for Alzheimer's disease-related dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA, 2011) criteria. (2) Diagnosed in Traditional Chinese Medicine as liver-kidney yin deficiency syndrome. (3) Aged 55–85 years old (inclusive of boundary values), both genders acceptable. (4) Clinical Dementia Rating (CDR) score of 1 or 2. (5) No prior use of any Alzheimer's disease treatment medications; or currently undergoing treatment, with the investigator's judgment that the medication may be discontinued. (6) At least 4 years of formal education, fluent in the local language, with Chinese reading, writing, and communication skills, and able to cooperate in completing clinical assessments as required by the study protocol. (7) The participant must have a stable and reliable caregiver who provides care for at least 4 days per week, at least 2 hours per day. The caregiver must accompany the participant to study visits and have sufficient interaction and communication with the participant to assist the investigator in completing relevant scale assessments. (8) Signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Cognitive impairment or dementia not caused by AD, including other neurodegenerative diseases (such as Lewy body dementia, frontotemporal dementia, Huntington's disease, Parkinson's disease, etc.), non-neurodegenerative diseases (such as vascular cognitive impairment or dementia, hydrocephalus, encephalitis, hypoxic brain injury, traumatic brain injury, etc.), central nervous system infections (such as HIV, syphilis, prion infections, etc.), other physicochemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), significant somatic diseases (such as hepatic encephalopathy, pulmonary encephalopathy, dialysis encephalopathy, etc.), intracranial space-occupying lesions (such as subdural hematoma, brain tumor), endocrine system disorders (such as thyroid disease, parathyroid disease), vitamin deficiencies (B1, B12, folic acid, etc.), or dementia caused by any other known reason; (2) Total score of the Modified Hachinski Ischemia Scale (mHIS) > 4 points; (3) History or current diagnosis of the following diseases: systemic lupus erythematosus (active disease may affect the nervous system and cause cognitive impairment), epilepsy (cognitive impairment may occur during episodes), schizophrenia or other mental disorders, bipolar disorder, moderate to severe depression or delirium (delirium in dementia patients may exacerbate cognitive impairment); (4) Unstable or severe cardiovascular, respiratory, digestive, urinary, hematological, endocrine system diseases within 6 months before the screening visit, as judged by the investigator to be unsuitable for clinical research, such as pancreatitis, severe/unstable angina, myocardial infarction, severe heart failure, life-threatening ventricular arrhythmias under maintenance treatment, pulmonary hypertension, respiratory failure, history of hypoglycemic coma, poorly controlled diabetes (HbA1c > 8.0% at screening), stroke (including transient ischemic attack), etc.; (5) Uncontrolled hypertension or hypotension at screening (defined as systolic blood pressure = 180 mmHg or < 90 mmHg, or diastolic blood pressure = 100 mmHg or < 60 mmHg after medication). Patients with mild deviations beyond this range judged by the investigator as clinically insignificant may not be excluded; (6) History of malignant tumors within the past 5 years (excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, or cured in situ carcinoma after radical resection); (7) History of alcoholism or drug abuse within the past year; (8) Gastrointestinal diseases that affect drug absorption or metabolism, swallowing difficulties within 6 months before the screening visit, or major gastrointestinal surgery within 3 months before the screening visit, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection, or those planning to undergo surgery during the trial; (9) Inability to complete required trial examinations due to personal reasons, such as contraindications to MRI scans; (10) Abnormal laboratory test results at screening and baseline: liver function (ALT, AST) exceeding twice the upper limit of normal; renal function (Cr) exceeding 1.5 times the upper limit of normal. Patients with mild deviations beyond this range judged by the investigator as clinically insignificant may not be excluded; (11) Presence of any of the following infections at screening: 1) HBsAg and/or HBcAb positive with positive HBV-DNA copy number (defined as exceeding the upper limit of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline, 12-week, and 24-week assessments using the following scales: MMSE (Mini-Mental State Examination), ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive Subscale), NPI (Neuropsychiatric Inventory), ADL (Activities of Daily Living Scale), CDR (Clinical Dementia Rating Scale); Traditional Chinese Medicine (TCM) Symptom Assessment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline, 12 weeks, and 24 weeks for metabolite markers: pathological products (Aß42, P-tau 217), axonal injury markers (neurofilament light chain), inflammatory markers (acidic protein of collagen fibers), 14,15-EET, endogenous nerve growth factor; cranial imaging examination.; | — |
Countries
China
Contacts
Public ContactZhongwei Guo
Tongde Hospital of Zhejiang Province
Outcome results
None listed