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Mild Cognitive ImpairmentNCT02353884

Multi-modality MRI Study on Prediction for Mild Cognitive Impairment Conversion

An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by XuanwuH 2 at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
How many people
150 participants
Where
1 siteChina
Study dates
Jan 2010to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Neurolgy,Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

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.

Read the detailed description

The cognition of MCI is between normal healthy and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD, so in this study, the investigators focus on the exploration of the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI, including structural MRI, functional MRI and DTI. Then the investigators further study the patients who convert to AD and explore their MRI characteristics on baseline, in order to construct the predictable classifier from MCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.

Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02353884
Study groupRoleWhat they receive
MCIp,MCIsprogressive MCI：those convert to AD in two years, stable MCI
MCI，HCmild cognitive impairment, healthy control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (3)

  1. characteristic changes of brain structure in progressive MCI

    voxel based morphometry (VBM) and cortical-thicknessanalysis（CTA）based on structural MRI were used to characterize the changes of brain structure in the MCIp comparing with the MCIs and healthy control

    Measured: 2 years

  2. characteristic changes of anatomical connectivity in progressing MCI

    region of interest(ROI),voxel and fiber bundle analysis based on diffusion tensor imaging were used to detect differences among the MCIp，MCIs and healthy control in fractional anisotropy(FA) and mean diffusivity(MD).

    Measured: 2 years

  3. characteristic changes of functional connectivity in progressing MCI

    functional connectivity（FC） was compared among the MCIp, MCIs and healthy control using resting-state functional magnetic resonance imaging.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353884
Sponsor's protocol ID
hanying3
Status last verified
Jan 2015
First submitted
4 Oct 2014
Last updated
3 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Li Z, Yan S, Zhao K, Wang D, Yao H, Zhou B, Zhang Z, Wang P, Liao Z, Chen Y, Zhang X, Han Y, Lu J, Liu Y. A neuroimaging biomarker for disease staging in clinically diagnosed Alzheimer's disease. BMC Med. 2026 Feb 5;24(1):145. doi: 10.1186/s12916-026-04674-6.

    PubMed 41639807

  • 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.

    PubMed 32716355

  • 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.

    PubMed 30618593

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by XuanwuH 2 at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the accuracy of a predictable classifier from MCI to AD based on Multi-Modality MRI characteristics of MCI patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02353884, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.

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