Alzheimer's Disease
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s disease assessment scale- cognitive subscale(ADAS-Cog);Alzheimer's Disease Cooperative Study -clinical global impression of change(ADCS-CGIC); | — |
Secondary
| Measure | Time frame |
|---|---|
| mini-mental state examination(MMSE);digital symbol substitution test(DSST);Trail Making Test (TMT);quality of life in Alzheimer’s disease(QOL-AD);Alzheimer’s disease cooperative study-activities of daily living(ADCS-ADL);neuropsychiatric inventory-clinician rating scale(NPI-C);clinical Interview-Based Impression of Change(CIBIC-plus); | — |
Countries
China
Contacts
Jiangsu Province Hospital of Chinese Medicine