Exploring the Predicting Biomarkers From Mild Cognitive Impairment to Dementia (EBMID)

NCT05697588 | Recruiting

• 1 other identifier: 2021ZD0201802
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Biomarkers; MCI Conversion to Dementia

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  5 years

Secondary Outcomes (13)

• Rate of change in differential protein content as assessed by CSF and blood samples.

  5 years

• Rate of change in small molecule metabolite as assessed by stool and urine.

  5 years

• Rate of change in metagenomes as assessed by stool samples.

  5 years

• Rate of change in classical AD protein biomarkers as assessed by CSF and blood samples.

  5 years

• Rate of change in sleep apnea hypopnea as assessed by Standard night Polysomnography.

  5 years

Study Arms (2)

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）

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cuibai Wei，Clinical Professor: lead
• 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

Study Sites (1)

Xuan Wu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, CSF, urine, faeces, saliva

Study Officials

• Cuibai Wei

  Xuan Wu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuibai Wei

CONTACT

83198319; weicb@xwhosp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: January 26, 2023
• Study Start: February 28, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-05

Locations

CN (1)