Clinical trial NCT02225964: Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Keywords: APOEε4
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2014-08-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aMCI patients with APOEε4

Brief summary: This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.

Detailed description: It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.

Eligibility criteria: Inclusion Criteria:

* Complaint about memory loss 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
* Failure to meet the criteria for dementia
* Carrying susceptible gene APOEε4
* Must be able to accept examination of MRI, sight and hearing allow to complete test

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 conversion of aMCI patients with APOEε4 to AD
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurolgy,Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
References:
citation: Lin H, Li M, Zhan Y, Lin L, Yang K, Hu S, Han Y. Disrupted white matter functional connectivity in aMCI APOEepsilon4 carriers: a resting-state study. Brain Imaging Behav. 2021 Aug;15(4):1739-1747. doi: 10.1007/s11682-020-00367-7.
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.
citation: Chen GQ, Sheng C, Li YX, Yu Y, Wang XN, Sun Y, Li HY, Li XY, Xie YY, Han Y. Neuroimaging basis in the conversion of aMCI patients with APOE-epsilon4 to AD: study protocol of a prospective diagnostic trial. BMC Neurol. 2016 May 12;16:64. doi: 10.1186/s12883-016-0587-2.