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

NCT ID: NCT02353845

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

normal control

No interventions assigned to this group

aMCIp

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

No interventions assigned to this group

aMCIs

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

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

XuanwuH 2

OTHER

Sponsor Role: lead

Responsible Party

XuanwuH 2

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

hanying2

Identifier Type: -

Identifier Source: org_study_id