NCT05697588 Exploring the Predicting Biomarkers From Mild Cognitive Impairment to Dementia (EBMID)
| NCT ID | NCT05697588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cuibai Wei，Clinical Professor |
| Condition | Biomarkers |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2023-02-28 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Cuibai Wei
PRINCIPAL INVESTIGATOR
Xuan Wu Hospital of Capital Medical University
Frequently Asked Questions
Who can join the NCT05697588 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Biomarkers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05697588 currently recruiting?
Yes, NCT05697588 is actively recruiting participants. Contact the research team at weicb@xwhosp.org for enrollment information.
Where is the NCT05697588 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05697588 clinical trial?
NCT05697588 is sponsored by Cuibai Wei，Clinical Professor. The principal investigator is Cuibai Wei at Xuan Wu Hospital of Capital Medical University. The trial plans to enroll 900 participants.