Alzheimer's Disease
Conditions
Interventions
Control group:Placebo, 5% of the effective ingredients of the investigational drug, unrecognizable in appearance, taken 3 times a day, 12g each time,diluted with warm water, and taken before meals.
Experimental group:Silkworm pupa powder, taken 3 times a day, 12g each time, diluted with warm water, and taken before meals.
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for dementia caused by AD as determined by the National Institute on Aging and the Alzheimer's Disease Association (NIA-AA) (2024); (2) Male or menopausal female (no fertility requirement), participants are 50-90 years old (inclusive) with primary school education or above; (3) The Mini Mental State Examination (MMSE) score for illiteracy is 2.0 points;; (4) 0 points< 40 points = the ADL Rating Scale; (5) At the time of screening and enrollment, there was a nutritional risk score of =3 points (according to the NRS2002 Nutritional Risk Screening Form); (6) In good general condition, ECOG score <= 3 points; (7) If you are receiving approved Alzheimer's disease treatment, such as acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists, you must maintain a stable dose for at least 12 weeks before baseline, and the cognitive evaluation scale is stable. Participants who have not been treated for Alzheimer's disease may be enrolled. Unless otherwise noted, participants must maintain a stable dose of all other (i.e., non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to baseline; (8) The investigator confirms that the subject has a stable and reliable caregiver; (9) You voluntarily participate in this clinical research, fully understand and be informed about the study, and sign the informed consent form (ICF).; Willing to follow and able to complete all trial procedures. If the participant lacks the capacity to consent in the opinion of the investigator, the participant's consent shall be obtained as required by local laws, regulations, and customs. (or signed by the patient's caregiver with the authorization of the patient's guardian) during the study to agree to provide peripheral blood, feces, urine, samples for biomarker analysis.
Exclusion criteria
Exclusion criteria: (1) Dementia caused by: Vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic cerebral dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), intracranial space-occupying lesions (such as subdural hematoma, brain Cancer), endocrine disorders (such as thyroid disease, adrenal disease) and dementia due to vitamins or any other cause; (2) Combined with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barre syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc. (3) Severe renal insufficiency: creatinine clearance 310 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc. During the screening period, patients with acute myocardial infarction or interventional therapy or heart failure (NYHA class III-IV patients) within the past 6 months; (patients with NYHA grade III-IV); Patients with other serious primary diseases of the nervous system, heart, lung, hematopoietic system or endocrine system and mental illness; (4) Suspected or indeed having a history of alcohol or drug abuse; (5) Expected survival time 26; (12) Activities of daily living (ADL) rating scale > 40 points (13) Patients with abnormally elevated tumor markers, history of tumor or undetermined tumor; (14) Those with serious suicide risk; (15) Patients with intolerance or allergy to the drugs used in the study; (16) Clinically significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or currently; (17) Antibiotic use: a. use of antibiotics for more than 10 consecutive days within 12 weeks before baseline; b. The subject is expected to receive antibiotics for more than 10 days; Any other medical condition (e.g., cardiac, respiratory, renal disease, gastrointestinal disease that could affect absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) was not stably and adequately controlled or was considered by the investigator to be likely to affect the safety of the participants or interfere with the study assessments; (18) Any other clinically significant abnormality in physical examination, vital signs, laboratory tests, or electrocardiogra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin;Albumin;Serum prealbumin;25-hydroxyvitamin D;Alkaline phosphatase;Parathyroid hormone;Calcitonin;Whole abdominal CT;Diagnostic criteria of the 2019 Asian Sarcopenia Working Group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-mental State Examination;Clinical Dementia Rating;Eastern Cooperative Oncology Group Score;Head MRI;Amyloid ß-protein,Aß;Microtubule-associated protein tau; | — |
Countries
China
Contacts
Public ContactYang Gaoyi
Hangzhou First People's Hospital
Outcome results
None listed