In recent years, reduced levels of brain-derived neurotrophic factor (BDNF) have been found in dementia patients. BDNF reduces amyloid precursor protein (APP) fragments via the Trk signaling pathway, and the expression of transgenic BDNF in animal models of Alzheimer's Disease(AD)shows a protective effect on neurodegeneration. A lot of researches have proved that brain hydrolysate injection can improve the level of BDNF in the brain. And oral brain peptide dietary supplements, which is also derived from brain proteolytic products, may also adjust and improve neuron metabolism, promote the formation of synapses, induce the differentiation of neurons, and protect nerve cells from ischemia and neurotoxin damage, reduce the risk of loss of cognitive function in the aging process. However, there are still no studies on dietary supplements derived from brain protein hydrolysates in China. Therefore, the investigators designed a randomized controlled double-blind study program to preliminarily evaluate the efficacy, safety and possible mechanism of brain polypeptide solution in improving the cognition of mild alzheimer's disease patients. The research is a prospective, multicenter, cohort study. 200 patients with mild alzheimer's disease will be selected and randomly divided into experimental group and control group according to the numerical random table. The experimental group will take the brain polypeptide solution 60ml per day and the control group was treated with the same package of placebo 60ml per day. The treatment regimen remained unchanged during the observation period. During the study period, safety index including blood and urine routine, liver and kidney function, coagulation index and clinical effect index about neuropsychological scales will be recorded.
The investigators design a prospective, multicenter, cohort study.200 patients with mild Alzheimer's disease will be selected and divided into brain polypeptide nutrient solution group (experimental group) and control group according to the numerical random table. The experimental group will take brain polypeptide solution 60ml per day, while the control group took placebo in the same package 60ml per day. The observation period is 84 days. And follow-up will take place at 42 and 84 days .The treatment regimen remained unchanged during the observation period. Safety indexes include blood and urine routine, liver and kidney function, coagulation index, etc. Screening indexes include syphilis antibody, HIV antibody, hepatitis b virus antibody, hepatitis c virus antibody, folic acid, vitamin B12, etc. Clinical outcome indicators include a number of scales to evaluate neurological and cognitive functions, such as the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog). Mechanism related indicators such as metabolomics was used to understand the possible differences in metabolic indicators. It is helpful to guide the use of brain polypeptide in Alzheimer's patients correctly .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
The experimental group will take the brain polypeptide solution 60ml per day which contains nitrogen 90mg, soybean oil ,glycerin and soybean phospholipids in 84days.
The control group was treated with the same package of placebo 60ml per day which contains soybean oil ,glycerin and soybean phospholipids in 84 days.
Changes of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog) scores
ADAS-cog will be performed to test the cognition of patients at the enrollment and week 12.The score ranges from 0 to 75,and higher values represent a better outcome.
Time frame: baseline time,week 12.
Changes of Alzheimer's Disease Collaborative research group-Activities of Daily Living(ADCS-ADL)scores
ADCS-ADL will be performed to test the activities of patients at the enrollment,week 6 and week12.The score ranges from 0 to 54,and higher values represent a better outcome.
Time frame: baseline time,week6,week 12.
Changes of Pittsburgh sleep quality index (PSQI) scores
PSQI will be performed to test the sleep quality of patients at the enrollment ,week 6 and week12.The score ranges from 0 to 21,and higher values represent a worse outcome.
Time frame: baseline time,week6,week 12.
Changes of Neuropsychiatric Inventory(NPI )scores
NPI will be performed to test the mental symptoms of patients at the enrollment and week12.The score ranges from 0 to 144,and higher values represent a worse outcome.
Time frame: baseline time,week 12.
Changes of ( Mini-Mental State Examination )MMSE scores
MMSE will be performed to test the cognition of patients at the enrollment and week12.The score ranges from 0 to 30,and higher values represent a better outcome.
Time frame: baseline time,week 12.
Changes of Montreal Cognitive Assessment (MoCA) scores
MoCA will be performed to test the cognition of patients at the enrollment and week12.The score ranges from 0 to 30,and higher values represent a better outcome.
Time frame: baseline time,week 12.
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