Skip to content

A prospective cohort study of Bushenyijing granules Intervention in early-stage Alzheimer's Disease

A prospective cohort study of Bushenyijing granules Intervention in early-stage Alzheimer's Disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004119
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

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

MeasureTime frame
Alzheimer's Disease Cooperative Study -clinical global impression of change(ADCS-CGIC);Alzheimer's disease assessment scale- cognitive subscale(ADAS-Cog);

Secondary

MeasureTime frame
digital symbol substitution test(DSST);Trail Making Test (TMT);clinical Interview-Based Impression of Change(CIBIC-plus);neuropsychiatric inventory-clinician rating scale(NPI-C);mini-mental state examination(MMSE);quality of life in Alzheimer's disease(QOL-AD);Alzheimer's disease cooperative study-activities of daily living(ADCS-ADL);

Countries

China

Contacts

Public ContactGuran Yu

Jiangsu Province Hospital of Chinese Medicine

dr.ydrdf@163.com+86 13912980709

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026