Predicting the Conversion From Mild Cognitive Impairment to Dementia (PCMCItoD)

August 18, 2021 updated by: Jinzhou Tian, Dongzhimen Hospital, Beijing

Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment

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.

Study Overview

Status

Completed

Conditions

Detailed Description

MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.

To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with cognitive complaint living in the community.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of conversion to dementia
Time Frame: At baseline, 26 weeks, and 52 weeks.
At baseline, 26 weeks, and 52 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini-Mental State Examination
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Immediate and delayed story recall
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Clock Drawing Test(CDT)
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Boston Naming Test
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Verbal Category Fluency Test(animals)
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Trail Making Test(TMT)
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks
Hopkins Verbal Learning Test(HVLT)
Time Frame: At baseline, 26 weeks, and 52 weeks
At baseline, 26 weeks, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongzhimen Hospital, Beijing

Investigators

  • Principal Investigator: Jinzhou Tian, Doctor, Dongzhimen Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 30, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z11107056811043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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