A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients with Alzheimer's Disease.

NCT06770309 | Not Yet Recruiting DMC

• 1 other identifier: syyycanyongfen
• 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 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.

Conditions

Alzheimer Disease (AD); Sarcopenia; Asthenia

Keywords

Alzheimer Disease; Sarcopenia; asthenia; nutritional status

Outcome Measures

Primary Outcomes (9)

• Hemoglobin

  Take blood testing and detect hemoglobin levels

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

• Albumin

  Detect blood albumin levels

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

• Serum prealbumin

  Detect serum prealbumin levels

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

• 25-hydroxyvitamin D

  Detect blood 25-hydroxyvitamin D levels

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

• Alkaline phosphatase

  Detect blood alkaline phosphatase levels

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

• Parathyroid hormone

  Detect parathyroid hormone levels

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

• Calcitonin

  Detect calcitonin levels

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

• Whole abdominal Computerized tomography (CT) scan

  Take the whole abdominal CT scan

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

• Diagnostic criteria of the 2019 Asian Sarcopenia Working Group

  Evaluate sarcopenia again

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

Secondary Outcomes (6)

• Mini-mental State Examination（MMSE） Scale

  The 4th、8th and 12th week after taking placebo.

• Clinical Dementia Rating（CDR） Scale

  The 4th 、8th and 12th week after taking placebo.

• Eastern Cooperative Oncology Group Score

  The 4th 、8th and 12th week after taking placebo.

• Head Magnetic Resonance Scan

  The 4th 、8th and 12th week after taking placebo.

• Amyloid β-protein（Aβ）

  The 4th 、8th and 12th week after taking placebo.

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:

• Meet the diagnostic criteria for dementia caused by AD as determined by the National Institute on Aging and the Alzheimer's Disease Association (NIA-AA) (2024);
• Male or menopausal female (no fertility requirement), participants are 50-90 years old (inclusive) with primary school education or above;
• The Mini Mental State Examination (MMSE) score for illiteracy is ≤ 17 points, primary school education is ≤ 20 points, secondary school education is ≤ 22 points, and university education is ≤ 23 points; CDR\>2.0 points;;
• points\< 40 points ≤ the ADL Rating Scale;
• At the time of screening and enrollment, there was a nutritional risk score of ≥3 points (according to the NRS2002 Nutritional Risk Screening Form);
• In good general condition, ECOG score ≤ 3 points;
• If you are receiving approved Alzheimer's disease treatment, such as acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists, you must maintain a stable dose for at least 12 weeks before baseline, and the cognitive evaluation scale is stable. Participants who have not been treated for Alzheimer's disease may be enrolled. Unless otherwise noted, participants must maintain a stable dose of all other (i.e., non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to baseline;
• The investigator confirms that the subject has a stable and reliable caregiver;
• You voluntarily participate in this clinical research, fully understand and be informed about the study, and sign the informed consent form (ICF).； Willing to follow and able to complete all trial procedures. If the participant lacks the capacity to consent in the opinion of the investigator, the participant's consent shall be obtained as required by local laws, regulations, and customs. (or signed by the patient's caregiver with the authorization of the patient's guardian) during the study to agree to provide peripheral blood, feces, urine, samples for biomarker analysis.

You may not qualify if:

• Dementia caused by the following reasons: vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic brain dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), important physical diseases ( Such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), intracranial mass lesions (such as subdural hematoma, brain tumors), endocrine system lesions (such as thyroid disease, adrenal gland disease) as well as dementia caused by vitamins or any other cause;
• Patients with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.;
• Severe renal insufficiency: creatinine clearance rate \< 30mL/min (Cockcroft-Gault formula).or other known severe renal insufficiency disease; Severe hepatic impairment: ALT or AST \> 10 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, liver cirrhosis, etc.; During the screening period, patients with acute myocardial infarction or interventional therapy in the past 6 months, and heart failure (patients classified as grade III-IV according to NYHA); Patients with other serious primary diseases of the nervous system, heart, pulmonary, hematopoietic system or endocrine system and psychiatric disorders;
• Those who suspect or have a history of alcohol or drug abuse;
• Estimated survival ≤ 3 months;
• Pregnant women or lactating women, subjects of childbearing age (including male subjects with heterosexual intercourse and their female partners of childbearing potential) who have pregnancy plans or are unwilling to take effective contraceptive measures from the beginning of screening to 3 months after discontinuation;
• Those who are allergic to the ingredients of known test supplies
• Participated in other drug clinical trials within 30 days before screening, or are participating in other clinical trials;
• Patients with other serious physical or psychiatric diseases or laboratory abnormalities that may increase the risk of participating in the study and who are considered by the investigator to be unsuitable for participating in this study
• Clinically severe mental disorder or psychiatric symptoms;
• Mini-Mental State Assessment Scale (MMSE) score \> 26 points;
• Activity of daily living ability (ADL) rating scale \> 40 points
• Patients with abnormally elevated tumor markers or a history of tumor or no clear tumor;
• Those who are at serious risk of suicide;
• Patients who are intolerant or allergic to the drugs used in this study;

Sponsors & Collaborators

• Yanbu Ke: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310022, China

Location

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

Gaoyi Yang

CONTACT

+86057156739127; keller416@126.com

Kaile Wang

CONTACT

+86057156739027; 576789954@qq.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: SPONSOR INVESTIGATOR
• PI Title: The director of Hangzhou First People's Hospital(Hangzhou Geriatric Hospital)

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 13, 2025
• Study Start: January 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

CN (1)