Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03978338
Status:
UNKNOWN
Last Update Posted:
2019-06-11
First Post:
2019-06-05
Brief Title:
A Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Mild Alzheimers Disease
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Multi-center Randomized Double-blind Controlled Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Improving Cognitive Function in Mild Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Alzheimers DiseaseADshows 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 alzheimers disease patients
The research is a prospective multicenter cohort study 200 patients with mild alzheimers 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 research is a prospective multicenter cohort study 200 patients with mild alzheimers 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
Detailed Description:
The investigators design a prospective multicenter cohort study200 patients with mild Alzheimers 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 Alzheimers 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 Alzheimers patients correctly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None