A Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Mild Alzheimer's Disease

NCT03978338 | Unknown DMC

• 1 other identifier: HS-1959
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Brain polypeptide

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline time,week 12.

Secondary Outcomes (5)

• Changes of Alzheimer's Disease Collaborative research group-Activities of Daily Living(ADCS-ADL)scores

  baseline time,week6,week 12.

• Changes of Pittsburgh sleep quality index (PSQI) scores

  baseline time,week6,week 12.

• Changes of Neuropsychiatric Inventory(NPI )scores

  baseline time,week 12.

• Changes of ( Mini-Mental State Examination )MMSE scores

  baseline time,week 12.

• Changes of Montreal Cognitive Assessment (MoCA) scores

  baseline time,week 12.

Study Arms (2)

Intervention group

EXPERIMENTAL

The experimental group will take the brain polypeptide solution .

Dietary Supplement: brain polypeptide solution

Control group

PLACEBO COMPARATOR

The control group was treated with the same package of placebo .

Other: same package of placebo

Interventions

brain polypeptide solution DIETARY_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.

Intervention group

same package of placebo OTHER

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.

Control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Zhitong Biopharma CO.,LTD: collaborator

Related Publications (6)

• 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.

  PMID: 28440854 BACKGROUND

• Kmietowicz 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.

  PMID: 26493230 BACKGROUND

• Alvarez 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.

  PMID: 16420392 BACKGROUND

• Gauthier 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.

  PMID: 25832905 BACKGROUND

• Alvarez 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.

  PMID: 21679156 BACKGROUND

• Muresanu 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.

  PMID: 18048059 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wei Chen, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Chen

CONTACT

010-69154095; chenw@pumch.cn

Xiaodong Shi

CONTACT

17888811579

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: July 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data is expected to be available after,September, 2020 and can be used forever.
• Access Criteria: The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.