An interventional study of Silkworm pupa powder in Alzheimer Disease, Sarcopenia and Asthenia, sponsored by Zhejiang Provincial Tongde Hospital. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Zhejiang Provincial Tongde Hospital · Not applicable, Interventional, and Treatment
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:
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:
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Zhejiang Provincial Tongde Hospital is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder
CIBIC-plus Score
The Clinician's Interview-Based Impression of Change Plus Caregiver Input is a semi-structured interview tool used to assess global clinical change in patients with dementia after treatment. The score ranges from 1 to 7, with 1 indicating very much improved, 4 indicating no change, and 7 indicating very much worsened.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder
MMSE Total Score
Mini-Mental State Examination (MMSE): A validated 30-point cognitive screening tool evaluating domains including orientation, memory, attention, language, and visuospatial abilities. Rationale: The dual assessment leverages: CIBIC-plus for holistic, clinician-judged disease progression (anchored to baseline severity). MMSE for quantifiable tracking of specific cognitive deficits.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial Tongde Hospital