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
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR). — 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). — 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). — 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). — 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). — 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). — 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). — 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). — 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.
Trial sites (1)
Facility
City
Region
Status
Xuan Wu Hospital of Capital Medical University
Beijing
Beijing Municipality
Recruiting
More Cuibai Wei，Clinical Professor trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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