Suspended
Shanghai Mental Health Center
What is being collected
Data Collection
Collected at a single point in time - Cross-sectionalDNA Samples
Who is being recruted
Mental Disorders+9
+ Brain Diseases
+ Central Nervous System Diseases
From 60 to 90 Years
+4 Eligibility Criteria
How is the trial designed
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Observational
Study Start: January 2012
Summary
Principal SponsorShanghai Mental Health Center
Study ContactTao Wang, M.D., Ph.D.More contacts
Last updated: February 19, 2014Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.The Real-Time PCR was the main method in the research.
Principal SponsorShanghai Mental Health Center
Study ContactTao Wang, M.D., Ph.D.More contacts
Last updated: February 19, 2014Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 60 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer DiseaseDisease
Criteria
3 inclusion criteria required to participate
AMCI was diagnosed based on the following criteria (Petersen et al., 2001): 1) memory complaint, preferably corroborated by a spouse or relative, 2) objective memory impairment, 3) normal general cognitive function, 4) intact activities of daily living, and 5) absence of dementia. We have amended the aMCI diagnostic criteria of the Petersen Mini-Mental State Examination (MMSE) cut-off score in order to be consistent with the low level of education in elderly Chinese people. Research (mingyuan Zhang et al, 1988) found that with the Chinese version of MMSE, AD subjects who had not been educated (NO ED) exhibited MMSE scores of < 18, those with elementary school education exhibited MMSE scores of < 21, and those with higher than middle school education exhibited MMSE scores of < 25. In the present study, the aMCI analysis was carried out on NO ED subjects with MMSE cut-off scores of over 18, elementary school educated subjects with MMSE cut-off scores of over 21, and higher than middle school educated subject with MMSE cut-off scores of over 25
Probable Alzheimer's disease (AD) was diagnosed according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria and the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorder's Association (NINCDS/ADRDA) criteria
The cognitively-normal elderly formed the normal control (NC) group, was independently-functioning community dwellers with no neurological or psychiatric conditions
1 exclusion criteria prevent from participating
All participants underwent a screening process that included a review of their medical history, physical and neurological examinations, laboratory tests, and MRI analysis. The clinical assessment of mild cognitive impairment or dementia included neuropsychological tests, as well as behavioral and psychiatric interviews conducted by the attending psychiatrist. AD patients recorded scores of < 4 on the Hachinski Ischemia Scale and showed no history of significant systemic or psychiatric conditions, or traumatic brain injuries that could compromise brain function
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Department of Psychogeriatrics，Shanghai Mental Health Center
Shanghai, ChinaOpen Department of Psychogeriatrics，Shanghai Mental Health Center in Google MapsSuspendedOne Study Center