A prospective cohort study of Bushenyijing granules Intervention in early-stage Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Registration Number
- ITMCTR2000004119
- Lead Sponsor
- Jiangsu Province Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients are diagnosed mild cognitive impairment due to Alzheimer's disease or dementia due to Alzheimer's disease meeting the criteria of National Institute on Aging-Alzheimer's Association workgroups(NIA-AA) on diagnostic guide lines for Alzheimer's disease(2011);
2. Patients aged between 65 and 85 years old;
3. Clinical Dementia Rating Scale(CDR) score i 0.5-2;
4. Hachinski ischemic scale(HIS)4 ;
5. Imaging evidencethe structural MRI image shows a disproportionate atrophy of the temporal and medial parietal lobes CSF biomarkers can be included, such as decreased A beta 42 or increased p-tau, T-tau;
6. Syndrome differentiation of TCM indicates deficiency of kidney and spleen;
7. Patients or their guardians voluntarily participate in the study and written the informed consent form.
1. Patients failed to cooperate with Cognitive function test;
2. Patients had a history of psychiatric drug or alcohol dependence for 6 months;
3. Participating in other cognitive related clinical studies currently;
4. Irritability;
5. Excluding other diseases that cause cognitive decline, such as: Hypothyroidism, Parkinson's disease, stroke, TIA, intracranial hemorrhage, focal brain injury, brain tumor, positive pressure hydrocephalus, lewy body dementia, frontotemporal lobar degeneration or other mental disorders accompanied by depression and anxiety;
6. Patients with severe diabetes or serious cardiovascular disease, cerebrovascular disease, liver disease, kidney disease, severe bone and joint disease and mental disorders.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method