Silkworm Pupa Powder Improves Alzheimer's Disease

NCT07638449 | Not Yet Recruiting DMC

• 1 other identifier: 2026-063(L)-F1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if silkworm pupa powder works to treat Alzheimer's disease in patients. It will also learn about the safety of silkworm pupa powder, and its effect on patients' nutritional and frailty status. The main questions it aims to answer are:

• Does silkworm pupa powder improve cognitive function and daily living abilities?
• Does silkworm pupa powder improve nutritional status and frailty?
• What medical problems do participants have when taking silkworm pupa powder? Researchers will evaluate the treatment by comparing the participants' conditions after taking the powder to their baseline conditions (a single-arm study without a placebo) to see if silkworm pupa powder works to treat Alzheimer's disease. Participants will:
• Take silkworm pupa powder every day for 12 weeks
• Visit the clinic once every 4 weeks for checkups and tests
• Use an electronic punch-card system daily and report any symptoms

Conditions

Alzheimer Disease; Sarcopenia; Asthenia; Frailty

Keywords

Silkworm Pupa Powder; Nutritional Status; Frailty State; Cognitive Function; Dietary Supplement

Outcome Measures

Primary Outcomes (18)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  The ADAS-Cog is a tool designed to assess the severity of cognitive impairment in patients with Alzheimer's disease (AD). It consists of 12 items that evaluate multiple cognitive domains, including memory, orientation, language, praxis (practical ability), attention, and others. Through a series of standardized cognitive tasks, it measures the severity of AD-related cognitive symptoms and tracks changes in response to treatment. Higher total scores indicate more severe cognitive impairment.

  The 0th、 4th 、8th and 12th week after taking Silkworm

• Bilateral Hippocampal Volume

  Bilateral hippocampal volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower hippocampal volume indicates greater AD-related brain atrophy.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Entorhinal Cortex Volume

  Entorhinal cortex volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower volume indicates greater AD-related brain atrophy.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Temporoparietal Regional Volume

  Temporoparietal regional volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower volume indicates greater AD-related brain atrophy.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Cortical Thickness of AD-Related Brain Regions

  Cortical thickness in AD-related brain regions, including the entorhinal cortex and temporoparietal cortex, will be measured using 3.0T structural MRI. Lower cortical thickness indicates greater cortical atrophy.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Fractional Anisotropy

  Fractional anisotropy will be measured using diffusion tensor imaging to assess white matter microstructural integrity. Lower fractional anisotropy generally indicates reduced white matter integrity.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Mean Diffusivity

  Mean diffusivity will be measured using diffusion tensor imaging to assess white matter microstructural changes. Higher mean diffusivity generally indicates greater microstructural disruption.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Radial Diffusivity

  Radial diffusivity will be measured using diffusion tensor imaging to assess white matter microstructural changes. Higher radial diffusivity generally indicates greater white matter microstructural abnormality.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Default Mode Network Functional Connectivity

  Functional connectivity of the default mode network will be assessed using resting-state functional MRI to evaluate AD-related brain network function.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Salience Network Functional Connectivity

  Functional connectivity of the salience network will be assessed using resting-state functional MRI to evaluate AD-related brain network function.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Amplitude of Low-Frequency Fluctuations

  Amplitude of low-frequency fluctuations will be measured using resting-state functional MRI to assess local spontaneous neuronal activity.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Regional Homogeneity

  Regional homogeneity will be measured using resting-state functional MRI to assess local synchronization of neuronal activity.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Blood Neurofilament Light Chain Concentration

  Neurofilament light chain concentration in blood will be measured as a biomarker of neuronal injury and neurodegeneration. Higher concentrations generally indicate greater neuronal injury.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Aβ42 Concentration in Blood or Cerebrospinal Fluid

  Aβ42 concentration in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Aβ40 Concentration in Blood or Cerebrospinal Fluid

  Aβ40 concentration in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Aβ42/Aβ40 Ratio in Blood or Cerebrospinal Fluid

  The Aβ42/Aβ40 ratio in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Phosphorylated Tau 181 Concentration in Blood or Cerebrospinal Fluid

  Phosphorylated tau 181 concentration in blood or cerebrospinal fluid will be measured as a biomarker of tau pathology in Alzheimer's disease.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• Phosphorylated Tau 217 Concentration in Blood or Cerebrospinal Fluid

  Phosphorylated tau 217 concentration in blood or cerebrospinal fluid will be measured as a biomarker of tau pathology in Alzheimer's disease.

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

Secondary Outcomes (2)

• CIBIC-plus Score

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

• MMSE Total Score

  The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

Study Arms (1)

Group

EXPERIMENTAL

Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months

Dietary Supplement: Silkworm pupa powder

Interventions

Silkworm pupa powder DIETARY_SUPPLEMENT

Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months

Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. Disease severity is classified as mild to moderate, defined as a Mini-Mental State Examination (MMSE) total score of 0-24 points, inclusive, at both screening and baseline.
• Confirmation of AD pathology per the 2024 revised AD diagnostic criteria (biomarker-defined AD with both Aβ and tau positivity):
• Aβ positivity: Plasma Aβ42/40 ratio ≤0.08 or amyloid-PET positivity (SUVR ≥1.1).
• Tau positivity: Plasma p-tau217 ≥2.5 pg/mL (or CSF p-tau181/Aβ42 ratio ≥0.02).
• Age 50 to 90 years (inclusive), male or female, with at least a primary school education.
• Stable medication use: If receiving approved AD therapies (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), doses must remain stable for ≥12 weeks prior to baseline. Treatment-naïve participants are also eligible. All other permitted non-AD related concomitant medications must remain stable for ≥4 weeks prior to baseline unless otherwise specified.
• Hachinski Ischemia Scale (HIS) total score ≤4.
• Geriatric Depression Scale-15 (GDS-15) total score ≤4.
• Neuroimaging evidence: Screening CT/MRI showing age-related brain changes or cerebral atrophy.
• Participant has a stable and reliable caregiver, as confirmed by the investigator.
• Written informed consent must be provided by the participant or, if the participant lacks decision-making capacity, by a legally authorized representative (in accordance with local laws, regulations, and customs). Participants must agree to provide peripheral blood, stool, and urine samples during the study for biomarker analysis.

You may not qualify if:

• Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders.
• Unstable vital signs accompanied by abnormalities in cardiac, pulmonary, hepatic, renal, or other organ functions.
• Abnormally low folate and/or vitamin B12 levels, or evidence that hypothyroidism has caused or exacerbated the participant's dementia. Abnormal syphilis test results.
• Comorbid psychiatric disorders.
• Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.
• Intolerance or allergy to the study medication (silkworm pupa powder).
• Abnormalities detected on cranial MRI, including ischemic or hemorrhagic infarctions, hydrocephalus, or brain tumors.
• Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or at present.
• Geriatric Depression Scale-15 (GDS-15) score \>4 at screening.
• Any other inadequately controlled condition (e.g., cardiac, respiratory, renal, or gastrointestinal disorders affecting absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
• Administration of any new chemical entity in an AD clinical study within 6 months prior to screening.
• Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures or safety.
• Participation in a clinical study involving therapeutic monoclonal antibodies, antibody-derived proteins, immunoglobulin therapy, or vaccines within 6 months prior to screening.
• Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapy and any BACE inhibitor therapy).
• Any inadequately controlled immune disorder, or immune disease requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives), systemic immunosuppressants, or plasmapheresis during the study.

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital: lead

Study Sites (1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310012, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Sarcopenia; Asthenia; Frailty

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Central Study Contacts

Jiangtao Zhang

CONTACT

+8618969125501; 18969125501@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)