Construction of Diagnosis System for Early AD Based on Multi-Modality MRI Technology

NCT02353845 | Completed DMC

• 1 other identifier: hanying2
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis

  two-hundred aMCI subjects and 100 normal controls recruited will undergo structure,resting-state functional magnetic resonance imaging and diffusion tensor imaging. An SVM classifier for diagnosis will be trained based on these neuroimaging data.Then leave-one-out cross validation will be used to estimate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of observations that are correctly classified into the aMCI or control groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCI images correctly classified,whereas the TN (true negative) is the number of control images correctly classified. The FP (false positive) is the number of control images classified as the aMCI, whereas the FN (false negative) is the number of aMCI images classified as controls.

  3 years

• number of participants correctly predicted by the SVM classifier for predicting conversion from aMCI to AD

  During 2-year follow-up, the group of aMCI will be divided into progressive aMCI (aMCIp) and stable aMCI（aMCIs）.According to the baseline neuroimaging data, an SVM classifier for predicting conversion from aMCI to AD will be trained. Then leave-one-out cross validation will be used to validate the performance of the classifier including accuracy，sensitivity，specificity.The classification accuracy will be measured by the proportion of aMCI that are correctly classified into the aMCIp or aMCIs groups.The sensitivity is defined as TP/(TP+FN), and specificity is defined as TN/(TN+FP). The TP (true positive) is the number of aMCIp images correctly classified,whereas the TN (true negative) is the number of aMCIs correctly classified. The FP (false positive) is the number of aMCIs classified as aMCIp, whereas the FN (false negative) is the number of aMCIp classified as aMCIs.

  3 years

Secondary Outcomes (2)

• regional cerebral metabolism (CMgl) measured by FDG-PET

  3 years

• changed regional cerebral blood flow measured by FDG-PET

  3 years

Study Arms (4)

aMCI

aMCI means a group of patients who do not qualify for a diagnosis of dementia but do display memory impairment beyond what is expected for their age and with regards to the educational history and with positive β-amyloid PET

normal control

aMCIp

progressive aMCI：aMCI subjects who will convert to AD during the follow-up period

aMCIs

stable aMCI：aMCI subjects who will not convert to AD during the follow-up period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• XuanwuH 2: lead

Study Sites (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: February 3, 2015
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

CN (1)