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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01823666
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

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.

Condition or disease
Mild Cognitive Impairment Alzheimer Disease Dementia, Vascular

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
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment
Study Start Date : September 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.
Normal cognition.

Primary Outcome Measures :
  1. Rate of conversion to dementia [ Time Frame: At baseline, 26 weeks, and 52 weeks. ]

Secondary Outcome Measures :
  1. Mini-Mental State Examination [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  2. Immediate and delayed story recall [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  3. Clock Drawing Test(CDT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  4. Boston Naming Test [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  5. Verbal Category Fluency Test(animals) [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  6. Trail Making Test(TMT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ]
  7. Hopkins Verbal Learning Test(HVLT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with cognitive complaint living in the community.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01823666

China, Beijing
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Beijing, Beijing, China, 100700
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Principal Investigator: Jinzhou Tian, Doctor Dongzhimen Hospital, Beijing

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jinzhou Tian, Professor, Dongzhimen Hospital, Beijing Identifier: NCT01823666     History of Changes
Other Study ID Numbers: Z11107056811043
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Jinzhou Tian, Dongzhimen Hospital, Beijing:
Alzheimer's disease
mild cognitive impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases