NCT02706210

Brief Summary

Dementia is one of the main chronic non-communicable diseases associated with disability, institutionalization, and mortality among elderly individuals. Alzheimer's disease (AD) and vascular dementia (VD) are considered to be the main types of dementia. A widely shared view is that future treatment strategies need to focus on treatment of the earliest stages of the disease. Mild cognitive impairment (MCI) constitutes an intermediate stage between normal aging and dementia. Vascular cognitive disorders (VCD) is an umbrella term representing a wide spectrum of cognitive disorder evoked by or associated with vascular causes. It encompasses patients suffering from a range of types of cognitive impairment, from mild impairment to VD. VCD predementia (VCD-P) is at the same stage of MCI. Amnestic MCI (aMCI) is a subtype of MCI, which is also considered to be the clinical transition stage between normal aging and AD, and has been applied to detect the emerging dementia. In VCD, infarcts or profuse white matter disease are considered the cause of cognitive decline. By contrast, AD is one of the most common progressive neurodegenerative disorders thought to be caused by amyloid aggregation and the formation of tau tangles. Both VCD-P and aMCI have a deficit in cognitive domains, and may have the same chief complaints of memory deficit. If it can be clear which will turn into what type of dementia in patients with cognitive impairment stage, it can not only make us more early intervention treatment to the patients, but also can save a lot of social resources and economic costs in clinic. By applying the resting state functional magnetic resonance (fMRI), structural magnetic resonance imaging (sMRI) and diffusion tensor magnetic resonance imaging (DTI) multimodal magnetic resonance (NMR) technology, the project comprehensive analysis comparison of neurodegenerative and blood vessels of brain function in patients with mild cognitive impairment and structural abnormalities connection mode. This project in order to reveal the cognitive impairment disease neural circuits in the development of the network connection and its change rule. People can further understand the pathogenesis of cognitive impairment, discover new will provide a scientific basis for prevention, diagnosis and treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 1, 2017

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

January 28, 2016

Last Update Submit

February 28, 2017

Conditions

Keywords

Mild Cognitive ImpairmentDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (3)

  • fractional anisotropy (FA)

    The diffusion tensor matrix would be generated from a series of diffusion weighted images, then the three eigenvalues or diffusivities, would be calculated by matrix diagonalization. FA represents the degree of anisotropy of the diffusion of water molecules in axons and decreased FA is a frequent correlate of brain tissue injury. It is a DTI parameter without units.

    about 3-5 years after they had a complaint of cognitive deficit

  • axial diffusivity (AxD)

    AxD represents the water diffusivity parallel to the axonal fibers, and therefore commonly linked to the microstructure of myelin. It is a DTI parameter without units.

    about 3-5 years after they had a complaint of cognitive deficit

  • radial diffusivity (RD)

    RD components of the diffusion metric provide indices of axonal integrity, measured as longitudinal diffusivity, and myelin integrity. It is a DTI parameter without units.

    about 3-5 years after they had a complaint of cognitive deficit

Study Arms (2)

vascular cognitive disorders pre-dementia (VCD-P)

amnestic mild cognitive impairment (aMCI)

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The recruited patients were outpatients who were registered at the neurology department.

You may qualify if:

  • For all the participants
  • Right-hand Chinese Han people
  • Sufficient with Mandarin language
  • For VCD-P group,
  • Clinical diagnosis of Vascular cognitive disorders
  • Between the stage of cognitive normal and dementia
  • Clinical diagnosis of subcortical vascular diseases
  • For aMCI group
  • Clinical diagnosis of aMCI
  • Between the stage of cognitive normal and dementia
  • The hippocampal atrophy confirmed by structural MRI

You may not qualify if:

  • psychiatric disease, neurological disorder and systemic disease
  • a suffering of visual abnormalities, severe aphasia or palsy
  • any medical or psychological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Hongqi Hospital of Mudanjiang Medical Universiy

Mudanjiang, Heilongjiang, China

RECRUITING

Related Publications (1)

  • Yu Y, Zhao W, Li S, Yin C. MRI-based comparative study of different mild cognitive impairment subtypes: protocol for an observational case-control study. BMJ Open. 2017 Mar 8;7(3):e013432. doi: 10.1136/bmjopen-2016-013432.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2016

First Posted

March 11, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2018

Last Updated

March 1, 2017

Record last verified: 2016-03

Locations