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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Dongzhimen Hospital, Beijing
Sponsor:
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT01823666
First received: March 30, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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
Mild Cognitive Impairment
Alzheimer Disease
Dementia, Vascular

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Dongzhimen Hospital, Beijing:

Primary Outcome Measures:
  • Rate of conversion to dementia [ Time Frame: At baseline, 26 weeks, and 52 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini-Mental State Examination [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Immediate and delayed story recall [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Clock Drawing Test(CDT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Boston Naming Test [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Verbal Category Fluency Test(animals) [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Trail Making Test(TMT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Hopkins Verbal Learning Test(HVLT) [ Time Frame: At baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 250
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with cognitive complaint living in the community.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823666

Contacts
Contact: Jingnian Ni, Doctor 86-10-84013132 Jingnian_ni@hotmail.com

Locations
China, Beijing
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100700
Contact: Jingnian Ni, Doctor    86-10-84013132    jingnian_ni@hotmail.com   
Principal Investigator: Jinzhou Tian, Doctor         
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Investigators
Principal Investigator: Jinzhou Tian, Doctor Dongzhimen Hospital, Beijing
  More Information

Additional Information:
No publications provided

Responsible Party: Jinzhou Tian, Professor, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT01823666     History of Changes
Other Study ID Numbers: Z11107056811043
Study First Received: March 30, 2013
Last Updated: August 27, 2014
Health Authority: China: Beijing Municipal Science and Technology Commission

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

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014