BiomarkersNCT05697588
Exploring the Predicting Biomarkers From Mild Cognitive Impairment to Dementia (EBMID)
An observational study of Biomarkers and MCI Conversion to Dementia, run by Cuibai Wei，Clinical Professor at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers, MCI Conversion to Dementia
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Cuibai Wei, 83198319, weicb@xwhosp.org
About this study
Official title: Studies on Biomarkers for Mild Cognitive Impairment Conversion to Dementia
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.
Read the detailed description
The 900 patients with MCI will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up for 5 years. According to the neuropsychological evaluation results of follow-up, the subjects were divided into MCI progression (MCI-P) and MCI stabilization (MCI-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with MCI included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to MCI conversion to dementia in the blood, cerebrospinal fluid, urine, saliva and feces. Using statistic and machine learning methods, the biomarkers and their combinations from MCI transmit to dementia could be obtained, and it can contribute to the construction of a risk prediction model and early warning evaluation system of MCI transmit to dementia.
- Conditions
- Biomarkers, MCI Conversion to Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCI progression | MCI-P (Compared with the baseline, MMSE score declined > 4 points per year) | |
| MCI stabilization | MCI-S (Compared with the baseline, MMSE score decreased < 4 points per year） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Rate of change in memory function as assessed by World Health Organization-Un-iversity of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function.
Measured: 5 years
Rate of change in language function as assessed by Boston Naming Test (BNT).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function.
Measured: 5 years
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI).
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best.
Measured: 5 years
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL).
Assess statistically significant difference between in score MCI-P and MCI-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability.
Measured: 5 years
Secondary outcomes (13)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Rate of change in sleep apnea hypopnea as assessed by Standard night Polysomnography.
Measured: 5 years
Rate of change in brain resting state activity as assessed by Resting state electroencephalogram (EEG).
Measured: 5 years
Rate of change in brain stem damage as assessed by Evoked potentials (EPs).
Measured: 5 years
Rates of change in brain structure using brain structure magnetic resonance imaging (sMRI).
Measured: 5 years
Rates of change in brain function characteristics using brain functional MRI (fMRI).
Measured: 5 years
Rates of change in white matter fiber bundle using Diffusion tensor image (DTI).
Measured: 5 years
Rates of change in glucose metabolism as measured by 18F-FDG-PET.
Measured: 5 years
Rates of change in amyloid deposition as measured by amyloid-PET
Measured: 5 years
Rates of change in tau deposition as measured by tau-PET.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Feb 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cuibai Wei，Clinical Professor
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University, Chinese PLA General Hospital, Chongqing Medical University, Tianjin Huanhu Hospital, Affiliated Zhongshan Hospital of Dalian University, First Hospital of Shijiazhuang City, Jilin University
- Responsible party
- Sponsor-investigator, Cuibai Wei，Clinical Professor, Xuanwu Hospital, Beijing
- Investigators
- Cuibai Wei, Principal investigator, Xuan Wu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697588
- Sponsor's protocol ID
- 2021ZD0201802
- Status last verified
- May 2025
- First submitted
- 1 Sep 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Biomarkers for Mild Cognitive Impairment Conversion to Dementia
- ClinicalTrials.gov ID
- NCT05697588
- Acronym / sponsor ID
- 2021ZD0201802
- Conditions
- Biomarkers, MCI Conversion to Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Cuibai Wei，Clinical ProfessorUniversity, hospital or other
- Collaborators
- Beihang University, Chinese PLA General Hospital, Chongqing Medical University, Tianjin Huanhu Hospital, Affiliated Zhongshan Hospital of Dalian University, First Hospital of Shijiazhuang City, Jilin University
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 26 Jan 2023 (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.
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.
Detailed description
The 900 patients with MCI will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up for 5 years. According to the neuropsychological evaluation results of follow-up, the subjects were divided into MCI progression (MCI-P) and MCI stabilization (MCI-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with MCI included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to MCI conversion to dementia in the blood, cerebrospinal fluid, urine, saliva and feces. Using statistic and machine learning methods, the biomarkers and their combinations from MCI transmit to dementia could be obtained, and it can contribute to the construction of a risk prediction model and early warning evaluation system of MCI transmit to dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI progression | – | –MCI-P (Compared with the baseline, MMSE score declined > 4 points per year) |
| MCI stabilization | – | –MCI-S (Compared with the baseline, MMSE score decreased < 4 points per year） |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- Male or female patients aged ≥50 and ≤85 years;
Key exclusion criteria (4 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).
Time frame: 5 years
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.
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE).
Time frame: 5 years
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.
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA).
Time frame: 5 years
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.
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).
Time frame: 5 years
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.
Rate of change in memory function as assessed by World Health Organization-Un-iversity of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT).
Time frame: 5 years
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function.
Rate of change in language function as assessed by Boston Naming Test (BNT).
Time frame: 5 years
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function.
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI).
Time frame: 5 years
Assess statistically significant difference in score between MCI-P and MCI-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best.
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL).
Time frame: 5 years
Assess statistically significant difference between in score MCI-P and MCI-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability.
13 secondary outcomes
Rate of change in differential protein content as assessed by CSF and blood samples.
Time frame: 5 years
Rate of change in small molecule metabolite as assessed by stool and urine.
Time frame: 5 years
Rate of change in metagenomes as assessed by stool samples.
Time frame: 5 years
Rate of change in classical AD protein biomarkers as assessed by CSF and blood samples.
Time frame: 5 years
Rate of change in sleep apnea hypopnea as assessed by Standard night Polysomnography.
Time frame: 5 years
Rate of change in brain resting state activity as assessed by Resting state electroencephalogram (EEG).
Time frame: 5 years
Rate of change in brain stem damage as assessed by Evoked potentials (EPs).
Time frame: 5 years
Rates of change in brain structure using brain structure magnetic resonance imaging (sMRI).
Time frame: 5 years
Rates of change in brain function characteristics using brain functional MRI (fMRI).
Time frame: 5 years
Rates of change in white matter fiber bundle using Diffusion tensor image (DTI).
Time frame: 5 years
Rates of change in glucose metabolism as measured by 18F-FDG-PET.
Time frame: 5 years
Rates of change in amyloid deposition as measured by amyloid-PET
Time frame: 5 years
Rates of change in tau deposition as measured by tau-PET.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Cuibai Wei principal investigator
Xuan Wu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers and MCI Conversion to Dementia, run by Cuibai Wei，Clinical Professor at 1 site in China.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuibai Wei (83198319, weicb@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR). (time frame: 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.