NCT01823666

Brief Summary

Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

March 30, 2013

Last Update Submit

August 18, 2021

Conditions

Mild Cognitive ImpairmentAlzheimer DiseaseDementia, Vascular

Keywords

DementiaAlzheimer's diseasemild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Rate of conversion to dementia

    At baseline, 26 weeks, and 52 weeks.

Secondary Outcomes (7)

  • Mini-Mental State Examination

    At baseline, 26 weeks, and 52 weeks

  • Immediate and delayed story recall

    At baseline, 26 weeks, and 52 weeks

  • Clock Drawing Test(CDT)

    At baseline, 26 weeks, and 52 weeks

  • Boston Naming Test

    At baseline, 26 weeks, and 52 weeks

  • Verbal Category Fluency Test(animals)

    At baseline, 26 weeks, and 52 weeks

  • +2 more secondary outcomes

Study Arms (2)

Mild cognitive impairment

People with cognitive complaint will be recruited. Who can be diagnosed as mild cognitive impairment will be enrolled according to the MCI criteria.

Control

Normal cognition.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with cognitive complaint living in the community.

You may qualify if:

  • complaint about cognitive decline compared to previous performance
  • objective cognitive impairment in one or more cognitive domains for age
  • preservation of independence in functional abilities
  • Mini-Mental State Examination(MMSE) scores between 24 and 30
  • a Clinical Dementia Rating(CDR) score of 0.5

You may not qualify if:

  • dementia
  • patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
  • depression(HAMD \>7) or psychosis
  • uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
  • current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
  • abnormal thyroid, low vitamin B12 level or low folic acid level
  • patient with visual and auditory disorders can't cooperate with neuropsychological assessment
  • patient can't cooperate with following up
  • informed consent is not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

  • Ni J, Shi J, Wei M, Tian J, Jian W, Liu J, Liu T, Liu B. Screening mild cognitive impairment by delayed story recall and instrumental activities of daily living. Int J Geriatr Psychiatry. 2015 Aug;30(8):888-90. doi: 10.1002/gps.4317. No abstract available.

    PMID: 26172064DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseDementia, VascularDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jinzhou Tian, Doctor

    Dongzhimen Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 4, 2013

Study Start

September 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

CN(1)