Study on prevention mild to moderate Alzheimer's disease from exacerbating through invigorating spleen and kidney

Phase 1

• Conditions: Alzheimer's disease

• Registration Number: ITMCTR2200006842
• Lead Sponsor: onghua Hospital Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.The diagnostic criteria of Western medicine and traditional Chinese medicine for Alzheimer's disease was met;
2.TCM syndrome differentiation belongs to the spleen and kidney deficiency type;
3.Clinical dementia rating,Montreal Cognitive Assessment,Mini-mental State Examination scale was used to screen patients with mild to moderate Alzheimer's disease (referring to CDR scale score of CDR score 1 or 2 patients 10 points =MMSE score < 27 points);
4.Both men and women aged 50-85 years old are acceptable;
5.Informed consent was obtained from patients or their family members to voluntarily participate in this study.

Exclusion Criteria

1.The diagnostic and inclusion criteria were not met;
2.Patients with severe neurological deficits such as hemiplegia, aphasia, and visual and hearing impairment;
3.Patients with cognitive impairment caused by other system diseases such as severe circulatory system, digestive system, urinary system, endocrine system and other diseases;
4.Patients with underlying diseases affecting the oral absorption and metabolism of drugs;
5.Patients with adverse addictions such as alcohol and drug abuse, psychotropic drug abuse and antidepressant drug abuse affected cognitive assessment;
6.Patients with serious life-threatening primary diseases and mental disorders;
7.People with allergic constitution;
8.Taking other cognitive-improving Chinese medicine or Chinese patent medicine;
9.Patients enrolled in other clinical trials within the past 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chinese Medicine Symptom Score Scale;Montreal Cognitive Assessment;Mini-mental State Examination;Alzheimer's Disease Assessment Scale-Cognitive section;

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale;Clinical Dementia Rating;Neuropsychiatric Inventory;