Clinical trial NCT02353884: Multi-modality MRI Study on Prediction for Mild Cognitive Impairment Conversion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2015-02-03
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cognition of MCI is between healthy control and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD.

Brief summary: The purpose of this study is to find the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI , including structural MRI, functional MRI and diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's disease (AD) based on Multi-Modality MRI characteristics of MCI patients.

Detailed description: The cognition of MCI is between normal healthy and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD, so in this study, the investigators focus on the exploration of the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI, including structural MRI, functional MRI and DTI. Then the investigators further study the patients who convert to AD and explore their MRI characteristics on baseline, in order to construct the predictable classifier from MCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.

Eligibility criteria: Inclusion Criteria:

* Age is between 55 to 75 years old
* Memory loss complaint and confirmed by an informant
* Cognitive impairment in single or multiple domains, adjusted for age and education
* Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
* A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
* Failure to meet the criteria for dementia
* Must be able to accept examination of MRI, sight and hearing allow to complete test
* Right handedness

Exclusion Criteria:

* Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
* People who have severe visual and hearing impairment

Primary outcomes:
measure: the accuracy of a predictable classifier from MCI to AD based on Multi-Modality MRI characteristics of MCI patients.
timeFrame: 2 years
Secondary outcomes:
measure: characteristic changes of brain structure in progressive MCI
timeFrame: 2 years
measure: characteristic changes of anatomical connectivity in progressing MCI
timeFrame: 2 years
measure: characteristic changes of functional connectivity in progressing MCI
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurolgy,Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
References:
citation: Sheng C, Sun Y, Wang M, Wang X, Liu Y, Pang D, Liu J, Bi X, Du W, Zhao M, Li Y, Li X, Jiang J, Han Y. Combining Visual Rating Scales for Medial Temporal Lobe Atrophy and Posterior Atrophy to Identify Amnestic Mild Cognitive Impairment from Cognitively Normal Older Adults: Evidence Based on Two Cohorts. J Alzheimers Dis. 2020;77(1):323-337. doi: 10.3233/JAD-200016.
citation: Yang L, Yan Y, Wang Y, Hu X, Lu J, Chan P, Yan T, Han Y. Gradual Disturbances of the Amplitude of Low-Frequency Fluctuations (ALFF) and Fractional ALFF in Alzheimer Spectrum. Front Neurosci. 2018 Dec 20;12:975. doi: 10.3389/fnins.2018.00975. eCollection 2018.