Alzheimer's Disease
Conditions
Interventions
Experimental group:Silkworm pupa powder, bid, 24 g per dose, taken with warm water before meals.
Sponsors
Tongde Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with probable Alzheimer's disease (AD) according to the diagnostic criteria of the National Institute on Aging and the Alzheimer's Association (NIA-AA), with mild to moderate disease severity, defined as a Mini-Mental State Examination (MMSE) total score ranging from 0 to 24 (inclusive) at screening and baseline; 2. Meeting the biologically defined AD pathology (positive for both Aß and tau) according to the 2024 revised AD diagnostic criteria: Aß positivity (plasma Aß42/40 ratio = 1.1); tau positivity (plasma p-tau217 >= 2.5 pg/mL, or CSF p-tau181/Aß42 >= 0.02); 3. Male and female participants aged 50 to 90 years (inclusive), with at least a primary school education level; 4. If receiving approved conventional AD treatments, such as acetylcholinesterase inhibitors, GV-971, or NMDA receptor antagonists, a stable dose must have been maintained for at least 12 weeks prior to baseline. Treatment-naïve participants are also eligible. Unless otherwise specified, participants must maintain stable doses of all other permitted concomitant medications (i.e., non-AD-related) for at least 4 weeks prior to baseline; 5. A total score of = 4 on the Hachinski Ischemic Scale (HIS); 6. A total score of = 4 on the 15-item Geriatric Depression Scale (GDS-15); 7. Evidence of age-related brain changes or brain atrophy on screening CT/MRI; 8. Confirmation by the investigator that the participant has a stable and reliable caregiver; 9. Provision of written informed consent. If the participant is deemed by the investigator to lack the capacity to consent, consent should be obtained according to local laws, regulations, and customs (to be signed by the patient's caregiver under the patient's authorization). Participants must agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study period.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders; 2. Unstable vital signs or abnormal organ function involving the heart, lungs, liver, kidneys, etc; 3. Abnormally low levels of folic acid and/or vitamin B12, or evidence that hypothyroidism contributes to or worsens the participant's dementia. Abnormal syphilis test results; 4. Concurrent psychiatric disorders; 5. Long-term alcohol abuse or drug misuse that may affect the evaluation of efficacy; 6. Intolerance or allergy to the investigational product used in this study; 7. Presence of other abnormalities on brain MRI, including ischemic or hemorrhagic infarction, hydrocephalus, brain tumor, etc; 8. Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within the past 12 months or currently; 9. A score > 4 on the 15-item Geriatric Depression Scale (GDS-15) at screening; 10. Any other disease (e.g., cardiac, respiratory, renal disease, gastrointestinal disorders that may affect absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) that is not stable and adequately controlled, or that in the investigator's opinion may affect participant safety or interfere with study assessments; 11. Participation in an AD clinical trial involving any new chemical entity within 6 months prior to screening; 12. Any other clinically significant abnormality on physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) that, in the investigator's opinion, requires further investigation or treatment, or may interfere with study procedures or safety; 13. Participation in a clinical study involving any therapeutic monoclonal antibody, monoclonal antibody-derived protein, immunoglobulin therapy, or vaccine within 6 months prior to screening; 14. Participation in a clinical study involving any anti-amyloid therapy (including any monoclonal antibody therapy and any beta-site amyloid precursor protein cleaving enzyme [BACE] inhibitor therapy); 15. Any inadequately controlled immune disease, or immune disease requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives thereof), systemic immunosuppressants, or plasmapheresis during the study period; 16. Participants with inadequately controlled bleeding disorders (including platelet count 1.5 for participants not receiving anticoagulant therapy, e.g., warfarin). Participants receiving anticoagulant therapy must be optimized for anticoagulation status and have been on a stable dose for at least 4 weeks prior to screening. Participants receiving anticoagulant therapy are not allowed to undergo cerebrospinal fluid (CSF) assessment; 17. Concurrent enrollment in another study at this site involving silkworm pupa powder intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer disease assessment scale-cog;Neurofilament Light Chain;Microtubule-associated protein tau;Resting-state Functional Magnetic Resonance Imaging;Diffusion Tensor Imaging;Structural MRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinicians Interview-Based Impression of Change Plus;Mini-mental State Examination; | — |
Countries
China
Contacts
Public ContactZhang Jiangtao
Tongde Hospital of Zhejiang Province
Outcome results
None listed