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

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ClinicalTrials.gov Identifier: NCT02353845
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
XuanwuH 2, Xuanwu Hospital, Beijing

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.

Condition or disease
Mild Cognitive Impairment Alzheimer's Disease

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.

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Study Type : Observational
Actual Enrollment : 297 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : November 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. number of participants correctly classified by the support vector machine (SVM) classifier for the aMCI diagnosis [ Time Frame: 3 years ]
    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.

  2. number of participants correctly predicted by the SVM classifier for predicting conversion from aMCI to AD [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. regional cerebral metabolism (CMgl) measured by FDG-PET [ Time Frame: 3 years ]
    different glucose consumption rate in some regions between aMCI and normal controls, and also between aMCIp and aMCIs

  2. changed regional cerebral blood flow measured by FDG-PET [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353845


Locations
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China, Beijing
Department of Neurolgy,Xuanwu Hospital of Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
XuanwuH 2
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Responsible Party: XuanwuH 2, Chief physician, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02353845    
Other Study ID Numbers: hanying2
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders