Exploring the Predicting Biomarkers From Mild Cognitive Impairment to Dementia (EBMID)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorCuibai Wei，Clinical Professor
About this trial
Mild cognitive impairment (MCI) represents a transitional stage between healthy aging and dementia, and affects more than 15% of the population over the age of 60 in China. About 15% patients with MCI could progress into dementia after two years and about one-third develop into dementia within five years, which will lead to suffering, as well as staggering economic and care burden. So, exploring the predicting biomarkers from MCI to dementia to identify and delay progression to dementia at an early stage is of great social and clinical significance. Some reports based on a single neural biomarker suggest that risk models can predict the conversion of MCI to dementia, but no widely recognized prediction models basing on multiple complex markers have been used in clinical practice. The objectives of this study are to outline the spectrum of MCI transforming into dementia through a 5-year prospective longitudinal cohort study; Secondly, screening biomarkers for MCI transmit to dementia are based on clinical symptoms, neuropsychology, neuroimaging, neuroelectrophysiology, and humoral markers tests data.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female patients aged ≥50 and ≤85 years;
Meet the diagnostic criteria for dementia or MCI; ③ Neuropsychological score: MMSE 15-28 points, CDR≤1 point; ④ The patients and their families were informed and signed the informed consent.
Disqualifiers
There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.);
There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
Suffering from a disease that cannot cooperate with the completion of cognitive examination; ④ There are contraindications to nuclear magnetic resonance;
There is mental and neurodevelopmental delay; ⑥ refuse to draw blood; ⑦ Refuse to sign the informed consent.
Trial population
This project will enroll about 900 patients with mild cognitive impairment (MCI), who meet the inclusion and exclusion criteria, including MCI due to AD (AD-MCI) \>350 participants, MCI due to frontotemporal dementia (FTD-MCI) \>150 participants, MCI due to dementia with Lewy bodies (DLB-MCI) \>150 participants, MCI due to vascular dementia (VaD-MCI) \>250 participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
900 Participants
are grouped into 2 trial groupsGroup A: MCI progression
Group B: MCI stabilization
Trial outcomes
Primary outcomes
1
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning.
Time frame
5 years2
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales MMSE. MMSE scores range from 0-30, with higher scores representing better cognitive function.
Time frame
5 years3
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales MoCA. MoCA scores range from 0-30, with higher scores representing better cognitive function.
Time frame
5 years4
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales ADAS-cog. ADAS-cog scores range from 0-70, with higher scores indicating better global cognitive function.
Time frame
5 yearsSecondary outcomes
1
Rate of change in differential protein content as assessed by CSF and blood samples.
Assess statistic difference in protein content between MCI-P and MCI-S using CSF and blood samples through proteomics DIA technology analysis.
Time frame
5 years2
Rate of change in small molecule metabolite as assessed by stool and urine.
Assess statistically significant difference in small molecule metabolite between MCI-P and MCI-S using stool and urine through untargeted metabolomics (LC-MS) analysis.
Time frame
5 years3
Rate of change in metagenomes as assessed by stool samples.
Assess statistically significant difference in transcription between MCI-P and MCI-S using stool samples through DNA high-throughput sequencing analysis.
Time frame
5 years4
Rate of change in classical AD protein biomarkers as assessed by CSF and blood samples.
Assess statistically significant difference in content between MCI-P and MCI-S using CSF and blood samples, through detecting the classical AD marker content.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cuibai Wei，Clinical Professor
Lead sponsor
Xuanwu Hospital, Beijing
Sponsor institution
Beihang University
Collaborator
Chinese PLA General Hospital
Collaborator
Chongqing Medical University
Collaborator
Tianjin Huanhu Hospital
Collaborator
Affiliated Zhongshan Hospital of Dalian University
Collaborator
First Hospital of Shijiazhuang City
Collaborator
Jilin University
Collaborator
Source ClinicalTrials.gov