Silkworm Pupa Powder Improves Dementia.

NCT06898476 | Recruiting DMC

• 1 other identifier: Jiangtao Zhang
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. The main questions it aims to answer are:

• Will silkworm pupa powder improve the daily living conditions of patients with Alzheimer's disease?
• Will silkworm pupa powder improve the nutritional status and frailty of Alzheimer's disease patients? Researchers will compare silkworm pupa powder with a placebo (a similar substance containing 0.5% silkworm pupa powder) to see if silkworm pupa powder can treat Alzheimer's disease. Participants will:
• Take silkworm pupa powder or placebo daily for four months;
• Visit the clinic for check-ups and tests every four weeks;
• Record their symptoms and various physiological indicators.

Conditions

Alzheimer Disease(AD); Sarcopenia; Asthenia

Keywords

Alzheimer Disease; Sarcopenia; asthenia; nutritional status; frailty state

Outcome Measures

Primary Outcomes (3)

• 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

• Frailty indicators

  This study employs serum 25-hydroxyvitamin D concentration as the central biomarker for frailty assessment. The selection is predicated on vitamin D's pivotal role in preserving musculoskeletal function and neuroprotective mechanisms, coupled with established evidence that suboptimal 25-hydroxyvitamin D levels exhibit significant correlations with geriatric frailty syndrome and cognitive decline. Through quantitative analysis via high-precision mass spectrometry, dynamic monitoring of vitamin D status alterations pre- and post-intervention will be conducted. Further investigation will elucidate its associations with frailty phenotypes (e.g., grip strength, gait speed) and dementia progression pathways.

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

• Frailty indicators

  Plasma D-dimer concentration has been incorporated into the core biomarker panel for frailty assessment.Change in plasma D-dimer levels from baseline to 12 months, measured by immunoassay, to evaluate its association with disease progression in Alzheimer's disease

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

Secondary Outcomes (2)

• Cognitive and Global Functional Assessment:

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

• Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI).

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

Study Arms (2)

Experimental 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

Control group

PLACEBO COMPARATOR

Placebo, 2 sachets (12\*2 g) twice a day, with warm water, before meals, for three months

Dietary Supplement: Placebo

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

Experimental Group

Placebo DIETARY_SUPPLEMENT

Placebo, 2 sachets (12\*2 g) twice a day, with warm water, before meals, for three months

Control 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, with disease severity classified as mild, moderate, or severe (i.e., Mini-Mental State Examination \[MMSE\] total score between 0 and 24 points \[inclusive\] at 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 of age (inclusive), with at least a primary school education. Both males and females are eligible.
• 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 non-AD-related permitted 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.
• Caregiver availability: Participant has a stable and reliable caregiver, as confirmed by the investigator.
• Informed consent: 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 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. Participants with abnormal syphilis test results.
• Patients with comorbid psychiatric disorders.
• Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.
• Participants with intolerance or allergy to the study medications.
• 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.
• Antibiotic use:
• Continuous antibiotic use for more than 10 days within 12 weeks prior to baseline.
• Anticipated need for antibiotic treatment exceeding 10 days during the study.
• 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.
• Participation in any clinical trial involving novel chemical entities for Alzheimer's disease (AD) within 6 months prior to screening, unless confirmed to have been in the placebo group.
• Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures/safety.

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital: lead
• Hangzhou Institute of Medicine Chinese Academy of Sciences: collaborator

Study Sites (1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310012, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Sarcopenia; Asthenia

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

Central Study Contacts

Jiangtao Zhang

CONTACT

+8618969125501; 18969125501@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jiangtao Zhang, Chief Physician

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

CN (1)