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New treatment option for AD - Alzheimer's Disease
Official title A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease.
ClinicalTrials.gov ID: NCT07059871
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- Meet the diagnostic criteria for probable dementia due to Alzheimer's disease (AD) as defined by the National Institute on Aging and Alzheimer's...
- Male or postmenopausal female (without childbearing potential). Participants aged 50-90 years (inclusive), with an education level of primary school...
- Mini-Mental State Examination (MMSE) score: ≤17 for illiterate, ≤20 for primary school education, ≤22 for secondary school education, ≤23 for...
- Activities of Daily Living (ADL) Scale score \>0 and ≤40.
- Nutritional Risk Screening (NRS 2002) score ≥3 at screening/enrollment.
You likely can't join if
- Dementia caused by: vascular dementia; CNS infections (e.g., AIDS, syphilis); Huntington's disease; Parkinson's disease; Lewy body dementia...
- Co-existing autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis...
- Severe renal impairment: Creatinine clearance \ 10 times the upper limit of normal (ULN), or other known liver diseases such as acute/chronic active...
- Suspected or confirmed history of alcohol or drug abuse.
- Life expectancy ≤3 months.
- Pregnant or lactating women. Participants of childbearing potential (including male participants engaging in heterosexual intercourse and their...
See the full eligibility criteria
Who can join
- Meet the diagnostic criteria for probable dementia due to Alzheimer's disease (AD) as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) (2024).
- Male or postmenopausal female (without childbearing potential). Participants aged 50-90 years (inclusive), with an education level of primary school or higher.
- Mini-Mental State Examination (MMSE) score: ≤17 for illiterate, ≤20 for primary school education, ≤22 for secondary school education, ≤23 for university education; Clinical Dementia Rating (CDR) global score \> 2.0.
- Activities of Daily Living (ADL) Scale score \>0 and ≤40.
- Nutritional Risk Screening (NRS 2002) score ≥3 at screening/enrollment.
- Good general health status, Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤3.
- If currently receiving approved AD treatments (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), must be on a stable dose for at least 12 weeks prior to baseline, with stable cognitive...
- Availability of a stable, reliable caregiver confirmed by the investigator.
- Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing and able to comply with and complete all trial procedures. If the...
What rules you out
- Dementia caused by: vascular dementia; CNS infections (e.g., AIDS, syphilis); Huntington's disease; Parkinson's disease; Lewy body dementia; traumatic brain injury-related dementia; other physical/chemical factors...
- Co-existing autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.
- Severe renal impairment: Creatinine clearance \ 10 times the upper limit of normal (ULN), or other known liver diseases such as acute/chronic active hepatitis, cirrhosis, etc.; Acute myocardial infarction or treatment...
- Suspected or confirmed history of alcohol or drug abuse.
- Life expectancy ≤3 months.
- Pregnant or lactating women. Participants of childbearing potential (including male participants engaging in heterosexual intercourse and their female partners of childbearing potential) planning pregnancy or unwilling...
- Known allergy/hypersensitivity to any component of the investigational product(s).
- Participation in another investigational drug trial within 30 days prior to screening or current participation in any other clinical trial.
- Presence of any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, makes the patient unsuitable for...
- Clinically significant psychiatric disorders or severe psychiatric symptoms.
- MMSE score \>26.
- ADL Scale score \>40.
- Clinically significant elevation of tumor markers, history of malignancy, or patients with tumors of undetermined nature.
- Significant risk of suicide.
- Chronic alcohol abuse or substance abuse that may interfere with how well it works evaluation.
- Intolerance or allergy to the drugs used in this study.
- Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within the past 12 months or current diagnosis.
- Antibiotic use: a. Continuous use of antibiotics for \>10 days within 12 weeks prior to baseline; b. Anticipated need for antibiotic treatment exceeding 10 days during the study. Any other disease (e.g., cardiac...
- Any other clinically significant abnormality in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) that, in the investigator's opinion, warrants further investigation or treatment, or may...
- Participants with inadequately controlled hemorrhagic disorders (including platelet count \ 1.5 for participants not on anticoagulant therapy like warfarin).
- Any other condition deemed by the investigator to make the participant unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.