Clinical trial NCT02353845: Construction of Diagnosis System for Early AD Based on Multi-Modality MRI Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 297
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aMCI is a group of patients whose memory are impaired to a greater degree than expected given the individual's age, sex, and educational background, while the individual's ability to perform the activities of daily living is preserved and the criteria for dementia are not met.

Brief summary: One purpose of this study is to construct the diagnosis system for early Alzheimer's disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI characteristics of aMCI patients.

Detailed description: The cognition of aMCI is between normal aging and dementia, which is thought the transitional stage of dementia. Patients with aMCI have heavy risk to convert to AD, so in this study, the investigators focus on the construction of the diagnosis system for early AD based on multi-modality MRI characteristics of aMCI patients. Every patient underwent β-Amyloid PET, fluorodeoxyglucose-PET(FDG-PET), structural MRI, diffusion tensor imaging and functional MRI. Then investigators further study the patients who convert to AD and explore their MRI and metabolism characteristics on baseline, in order to construct the predictable classifier from aMCI 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:

* 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: number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis
timeFrame: 3 years
measure: number of participants correctly predicted by the SVM classifier for predicting conversion from aMCI to AD
timeFrame: 3 years
Secondary outcomes:
measure: regional cerebral metabolism (CMgl) measured by FDG-PET
timeFrame: 3 years
measure: changed regional cerebral blood flow measured by FDG-PET
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurolgy,Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
References: