NCT02353884

Brief Summary

The purpose of this study is to find the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI , including structural MRI, functional MRI and diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's disease (AD) based on Multi-Modality MRI characteristics of MCI patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

October 4, 2014

Last Update Submit

January 28, 2015

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • the accuracy of a predictable classifier from MCI to AD based on Multi-Modality MRI characteristics of MCI patients.

    one-hundred MCI subjects and 50 healthy controls recruited underwent structure,resting-state functional magnetic resonance imaging and diffusion tensor imaging.After 2-year follow-up,the MCI subjects were divided into progressive MCI(MCIp) and stable MCI(MCIs).Based on differences among MCIp，MCIs and healthy controls in baseline neuroimaging data，some suitable indicators were selected，and then a predictable classifier from MCI to AD based on multi-modality MRI was constructed.At last，the leave-one-out cross validation analysis were conducted to estimate the accuracy of the classifier.The classification accuracy was measured by the proportion of MCI subjects that were correctly classified into the MCIp or MCIs groups

    2 years

Secondary Outcomes (3)

  • characteristic changes of brain structure in progressive MCI

    2 years

  • characteristic changes of anatomical connectivity in progressing MCI

    2 years

  • characteristic changes of functional connectivity in progressing MCI

    2 years

Study Arms (2)

MCIp,MCIs

progressive MCI：those convert to AD in two years, stable MCI

MCI，HC

mild cognitive impairment, healthy control

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The cognition of MCI is between healthy control and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD.

You may qualify if:

  • Age is between 55 to 75 years old
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (2)

  • Sheng C, Sun Y, Wang M, Wang X, Liu Y, Pang D, Liu J, Bi X, Du W, Zhao M, Li Y, Li X, Jiang J, Han Y. Combining Visual Rating Scales for Medial Temporal Lobe Atrophy and Posterior Atrophy to Identify Amnestic Mild Cognitive Impairment from Cognitively Normal Older Adults: Evidence Based on Two Cohorts. J Alzheimers Dis. 2020;77(1):323-337. doi: 10.3233/JAD-200016.

    PMID: 32716355DERIVED

  • 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.

    PMID: 30618593DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative 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 4, 2014

First Posted

February 3, 2015

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations

CN(1)