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.
Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Dietary Supplement: brain polypeptide solution Other: same package of placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Alzheimer's Disease |
Estimated Study Start Date : | July 2019 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | September 2020 |
Arm | Intervention/treatment |
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Experimental: Intervention group
The experimental group will take the brain polypeptide solution .
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Dietary Supplement: brain polypeptide solution
The experimental group will take the brain polypeptide solution 60ml per day which contains nitrogen 90mg, soybean oil ,glycerin and soybean phospholipids in 84days.
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Placebo Comparator: Control group
The control group was treated with the same package of placebo .
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Other: same package of placebo
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.
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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wei Chen | 010-69154095 | chenw@pumch.cn | |
Contact: Xiaodong Shi | 17888811579 |
Principal Investigator: | Wei Chen, M.D. | Peking Union Medical College Hospital |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | June 5, 2019 | ||||||||||||||||
First Posted Date ICMJE | June 7, 2019 | ||||||||||||||||
Last Update Posted Date | June 11, 2019 | ||||||||||||||||
Estimated Study Start Date ICMJE | July 2019 | ||||||||||||||||
Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Changes of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog) scores [ Time Frame: baseline time,week 12. ] 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.
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Original Primary Outcome Measures ICMJE |
Changes of ADAS-cog scores [ Time Frame: baseline time,week 12. ] ADAS-cog will be perfomed to test the cognition of patients at the enrollment and week 12.
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Mild Alzheimer's Disease | ||||||||||||||||
Official Title ICMJE | A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Improving Cognitive Function in Mild Alzheimer's Disease | ||||||||||||||||
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 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. |
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Detailed Description | 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 ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer Disease | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Unknown status | ||||||||||||||||
Estimated Enrollment ICMJE |
200 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | September 2020 | ||||||||||||||||
Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03978338 | ||||||||||||||||
Other Study ID Numbers ICMJE | HS-1959 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wei Chen, Peking Union Medical College Hospital | ||||||||||||||||
Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||||||||||||||
Collaborators ICMJE | Zhitong Biopharma CO.,LTD | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Peking Union Medical College Hospital | ||||||||||||||||
Verification Date | June 2019 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |