Alzheimer DiseaseNCT03978338
A Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Mild Alzheimer's Disease
A study testing brain polypeptide solution in people with Alzheimer Disease, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- brain polypeptide solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 50 to 85 (including 50 and 85 years old), regardless of ethnic group or gender;
- The subjects should be able to complete the cognitive ability measurement and other tests specified in the protocol;
- meeting the criteria for likely Alzheimer's Disease （AD） dementia (2007) by National Institute of Neurological Disorders and Strokes - Alzheimer's Disease and Related Diseases Association（NINCDS-ADRDA）;
- patients with mild dementia: the total score of Mini-Mental State Examination (MMSE) : illiteracy ≤17 points, primary school ≤20 points, secondary school ≤22 points, university ≤23 points; Clinical Dementia Rating scale （CDR） = 1 point;
- the total score of the Hachinski Ischemic Score （HIS ）was < 4.
- Hamilton depression scale (17 items) total score ≤7 points;
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- Brain MRI shows a high likelihood of AD;
- before enrollment, patients should take a stable dose of dementia drugs (such as donepezil 10mg) ≥8 weeks;
- the expected survival time is > 1 year;
- subjects should have a stable and reliable caregiver, or at least have frequent contact with the caregiver (at least 3 days per week and at least 2 hours per day), who will help patients participate in the whole study; Caregivers must accompany the subjects to the visit and assist in completing the relevant scale.
Who cannot join
- refuse to sign the inform consent form;
- other causes of dementia: known vascular, central nervous system infection ,Parkinson's disease, traumatic brain dementia, other physical and chemical factors; serious body disease , intracranial space-occupying lesions, endocrine system disease, such as thyroid disease, and a lack of vitamin B12, folic acid, or any other known causes of dementia.
- central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
- obvious positive signs of nervous system examination;
- psychotic patients, including schizophrenia or other disorders with bipolar disorder, major depression or delirium;
- uncontrolled hypertension or hypotension during screening: systolic blood pressure ≥180（millimetres of mercury ）mmHg or < 90mmhg, or diastolic blood pressure ≥120mmHg or < 60mmhg;
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- unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
- patients with incurable visual and auditory disorders that cannot complete neuropsychological tests and scales;
- female subjects who are positive in pregnancy test or breast-feeding and who cannot take effective contraceptive measures or have a birth plan;
- severe allergy, non-allergic drug reaction or multi-drug allergy history;
- participated in other clinical trials within 3 months before screening visit;
- taking any health care products related to brain and brain improvement currently and failing to keep the promise to stop using the above products;
- other conditions are unsuitable for participating in this study according to the judgement of researchers.
Trial locations and contacts
No sites are listed yet.
Xiaodong Shi contact
About this study
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
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.
Read the 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 .
- Conditions
- Alzheimer Disease
- Being tested
- brain polypeptide solution, same package of placebo
- Keywords
- Alzheimer Disease, Brain polypeptide
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain polypeptide solutionDietary supplement
The experimental group will take the brain polypeptide solution 60ml per day which contains nitrogen 90mg, soybean oil ,glycerin and soybean phospholipids in 84days.
same package of placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group will take the brain polypeptide solution . Receives: Dietary Supplement: brain polypeptide solution |
| Control group | Placebo comparator | The control group was treated with the same package of placebo . Receives: Other: same package of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline time,week 12.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline time,week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhitong Biopharma CO.,LTD
- Responsible party
- Principal investigator, Wei Chen, Peking Union Medical College Hospital
- Investigators
- Wei Chen, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978338
- Sponsor's protocol ID
- HS-1959
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data will be shared at the end of the study: demographic data, current medical history, past history,physical examination data and date of neuropsychological evaluation collected at this research.
Publications
McEvoy CT, Guyer H, Langa KM, Yaffe K. Neuroprotective Diets Are Associated with Better Cognitive Function: The Health and Retirement Study. J Am Geriatr Soc. 2017 Aug;65(8):1857-1862. doi: 10.1111/jgs.14922. Epub 2017 Apr 25.
PubMed 28440854Kmietowicz Z. Mediterranean diet is associated with reduced brain shrinkage in older people, study finds. BMJ. 2015 Oct 21;351:h5556. doi: 10.1136/bmj.h5556. No abstract available.
PubMed 26493230Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease. Eur J Neurol. 2006 Jan;13(1):43-54. doi: 10.1111/j.1468-1331.2006.01222.x.
PubMed 16420392Gauthier S, Proano JV, Jia J, Froelich L, Vester JC, Doppler E. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332-47. doi: 10.1159/000377672. Epub 2015 Mar 26.
PubMed 25832905Alvarez XA, Cacabelos R, Sampedro C, Couceiro V, Aleixandre M, Vargas M, Linares C, Granizo E, Garcia-Fantini M, Baurecht W, Doppler E, Moessler H. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil. Curr Alzheimer Res. 2011 Aug;8(5):583-91. doi: 10.2174/156720511796391863.
PubMed 21679156Muresanu DF, Alvarez XA, Moessler H, Buia M, Stan A, Pintea D, Moldovan F, Popescu BO. A pilot study to evaluate the effects of Cerebrolysin on cognition and qEEG in vascular dementia: cognitive improvement correlates with qEEG acceleration. J Neurol Sci. 2008 Apr 15;267(1-2):112-9. doi: 10.1016/j.jns.2007.10.016. Epub 2007 Nov 28.
PubMed 18048059
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03978338
- Acronym / sponsor ID
- HS-1959
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Brain polypeptide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Zhitong Biopharma CO.,LTD
- Study start
- Jul 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: brain polypeptide solutionThe experimental group will take the brain polypeptide solution . |
| Control group | Placebo comparator | Other: same package of placeboThe control group was treated with the same package of placebo . |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age range from 50 to 85 (including 50 and 85 years old), regardless of ethnic group or gender;
- The subjects should be able to complete the cognitive ability measurement and other tests specified in the protocol;
- meeting the criteria for likely Alzheimer's Disease （AD） dementia (2007) by National Institute of Neurological Disorders and Strokes - Alzheimer's Disease and Related Diseases Association（NINCDS-ADRDA）;
- patients with mild dementia: the total score of Mini-Mental State Examination (MMSE) : illiteracy ≤17 points, primary school ≤20 points, secondary school ≤22 points, university ≤23 points; Clinical Dementia Rating scale （CDR） = 1 point;
- the total score of the Hachinski Ischemic Score （HIS ）was < 4.
Key exclusion criteria (13 listed)
- refuse to sign the inform consent form;
- other causes of dementia: known vascular, central nervous system infection ,Parkinson's disease, traumatic brain dementia, other physical and chemical factors; serious body disease , intracranial space-occupying lesions, endocrine system disease, such as thyroid disease, and a lack of vitamin B12, folic acid, or any other known causes of dementia.
- central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
- obvious positive signs of nervous system examination;
- psychotic patients, including schizophrenia or other disorders with bipolar disorder, major depression or delirium;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brain polypeptide solutionThe experimental group will take the brain polypeptide solution 60ml per day which contains nitrogen 90mg, soybean oil ,glycerin and soybean phospholipids in 84days. | Dietary supplement | Intervention group |
| same package of placeboThe control group was treated with the same package of placebo 60ml per day which contains soybean oil ,glycerin and soybean phospholipids in 84 days. | Other | Control group |
Primary outcome
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.
5 secondary outcomes
Changes of Alzheimer's Disease Collaborative research group-Activities of Daily Living(ADCS-ADL)scores
Time frame: baseline time,week6,week 12.
Changes of Pittsburgh sleep quality index (PSQI) scores
Time frame: baseline time,week6,week 12.
Changes of Neuropsychiatric Inventory(NPI )scores
Time frame: baseline time,week 12.
Changes of ( Mini-Mental State Examination )MMSE scores
Time frame: baseline time,week 12.
Changes of Montreal Cognitive Assessment (MoCA) scores
Time frame: baseline time,week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Background: PubMed 28440854McEvoy CT, Guyer H, Langa KM, Yaffe K. Neuroprotective Diets Are Associated with Better Cognitive Function: The Health and Retirement Study. J Am Geriatr Soc. 2017 Aug;65(8):1857-1862. doi: 10.1111/jgs.14922. Epub 2017 Apr 25.
- Background: PubMed 26493230Kmietowicz Z. Mediterranean diet is associated with reduced brain shrinkage in older people, study finds. BMJ. 2015 Oct 21;351:h5556. doi: 10.1136/bmj.h5556. No abstract available.
- Background: PubMed 16420392Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease. Eur J Neurol. 2006 Jan;13(1):43-54. doi: 10.1111/j.1468-1331.2006.01222.x.
- Background: PubMed 25832905Gauthier S, Proano JV, Jia J, Froelich L, Vester JC, Doppler E. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332-47. doi: 10.1159/000377672. Epub 2015 Mar 26.
- Background: PubMed 21679156Alvarez XA, Cacabelos R, Sampedro C, Couceiro V, Aleixandre M, Vargas M, Linares C, Granizo E, Garcia-Fantini M, Baurecht W, Doppler E, Moessler H. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil. Curr Alzheimer Res. 2011 Aug;8(5):583-91. doi: 10.2174/156720511796391863.
- Background: PubMed 18048059Muresanu DF, Alvarez XA, Moessler H, Buia M, Stan A, Pintea D, Moldovan F, Popescu BO. A pilot study to evaluate the effects of Cerebrolysin on cognition and qEEG in vascular dementia: cognitive improvement correlates with qEEG acceleration. J Neurol Sci. 2008 Apr 15;267(1-2):112-9. doi: 10.1016/j.jns.2007.10.016. Epub 2007 Nov 28.
- Individual participant dataSharing planned: Yes. The following data will be shared at the end of the study: demographic data, current medical history, past history,physical examination data and date of neuropsychological evaluation collected at this research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaodong Shi contact
Wei Chen, M.D. principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing brain polypeptide solution in people with Alzheimer Disease, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen (010-69154095, chenw@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog) scores (time frame: baseline time,week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978338, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.