Silkworm Pupa Powder Improves Dementia.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorZhejiang Provincial Tongde Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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).
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Silkworm pupa powder
- Placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhejiang Provincial Tongde Hospital
Lead sponsor
Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Collaborator
Source ClinicalTrials.gov