A Prospective, Double-blind, Randomized Controlled Clinical Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease
The goal of this clinical trial is to learn if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients. The main questions it aims to answer are: * Does silkworm pupa powder evaluate the effectiveness of silkworm pupae in improving sarcopenia, frailty and quality of life in AD patients? * Does silkworm pupa powder improve cognitive function in AD patients? Researchers will compare silkworm pupa powder to a placebo (a look-alike substance that contains no drug) to see if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients. Participants will: * Take drug silkworm pupa powder or a placebo every day for 3 months. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their daily consumption.
• Meet the diagnostic criteria for probable dementia due to Alzheimer's disease (AD) as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) (2024).
• Male or postmenopausal female (without childbearing potential). Participants aged 50-90 years (inclusive), with an education level of primary school or higher.
• Mini-Mental State Examination (MMSE) score: ≤17 for illiterate, ≤20 for primary school education, ≤22 for secondary school education, ≤23 for university education; Clinical Dementia Rating (CDR) global score \> 2.0.
• Activities of Daily Living (ADL) Scale score \>0 and ≤40.
• Nutritional Risk Screening (NRS 2002) score ≥3 at screening/enrollment.
• Good general health status, Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤3.
• If currently receiving approved AD treatments (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), must be on a stable dose for at least 12 weeks prior to baseline, with stable cognitive assessment scores. Treatment-naïve participants for AD are eligible. Unless otherwise specified, all other permitted concomitant medications (non-AD related) must be stable for at least 4 weeks prior to baseline.
• Availability of a stable, reliable caregiver confirmed by the investigator.
• Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing and able to comply with and complete all trial procedures. If the participant, in the investigator's judgment, lacks capacity to consent, consent must be obtained according to local laws, regulations, and customs (or signed by the patient's caregiver under the authorization of the patient's legal guardian). Agrees to provide peripheral blood, stool, and urine samples for biomarker analysis during the study.