Plain English Summary
Background and study aims
Alzheimer’s disease (AD) is the most common cause of senile dementia. The understanding and study of amnestic mild cognitive impairment (aMCI) (problems with memory) is important in the diagnosis of AD. Annually, about 15% of aMCI patients develop AD, and over a period of 7 years, 80% will develop AD. Modern neuroimaging techniques can aid the diagnosis of AD, particularly for aMCI patients. The aim of this study is to test the sensitivity of diffusion kurtosis imaging (DKI) for assessing differences in the brains of patients with Alzheimer’s disease and aMCI.
Who can participate?
AD patients, aMCI patients, and healthy volunteers
What does the study involve?
DKI is used to inspect the hippocampus (part of the brain) of the three groups.
What are the possible benefits and risks of participating?
As the sensitivity of the DKI technique for the assessment of hippocampal differences between aMCI and AD patients has not been comprehensively investigated, this study served as an exploratory study of AD and aMCI.
Where is the study run from?
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital (China)
When is the study starting and how long is it expected to run for?
January 2010 to December 2018
Who is funding the study?
Shanghai Jiao Tong University School of Medicine (China)
Who is the main contact?
Dr Guoping Song
songgp1979@163.com
Trial website
Contact information
Type
Public
Primary contact
Dr Guoping Song
ORCID ID
Contact details
No.600
Yishan Road
Shanghai
200233
China
+86 (0)21 64844183
songgp1979@163.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1.0
Study information
Scientific title
Differentiating Alzheimer’s disease, amnestic mild cognitive impairment and normal aging using diffusion kurtosis imaging parameters
Acronym
Study hypothesis
To study the sensitivity of diffusion kurtosis imaging in assessing hippocampal differences between patients with Alzheimer’s disease and amnestic mild cognitive impairment.
Ethics approval
Approved 04/05/2010, Ethics Review Board of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital (Sun Xiuxiu, Ethical Office, 1st Floor, Teaching Building, 600 Yishan Road, Shanghai, China; Tel: +86 (0)2124056248), approval No. 2010(C)-6
Study design
Cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Alzheimer’s disease, amnestic mild cognitive impairment, normal aging
Intervention
This study comprised 20 Alzheimer’s disease patients (11 males and 9 females, mean, 73.2 ± 4.49 years), 20 amnestic mild cognitive impairment patients (10 males and 10 females, mean 71.55 ± 4.77 years), and 20 normal controls (11 males and 9 females, mean 70.45 ± 5.04 years). A 3.0T magnetic resonance scanner was utilized for diffusion kurtosis imaging to compare the difference in the hippocampus among the three groups.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Mean kurtosis measured by a 3.0T magnetic resonance scanner (MAGETOM, Verio, Siemens Healthcare, Erlangen, Germany), with a 32-channel head coil after hospitalization
Secondary outcome measures
Mean diffusion, fractional anisotropy and volume of bilateral hippocampus, measured by a 3.0T magnetic resonance scanner (MAGETOM, Verio, Siemens Healthcare, Erlangen, Germany), with a 32-channel head coil after hospitalization
Overall trial start date
01/01/2010
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The AD group was diagnosed according to the following criteria (McKhann et al., 1984):
1. Based on the Diagnostic and Statistical Manual of Mental Disorders IV and the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association criteria
2. A mini-mental state examination score of ≤ 23
Petersen diagnostic criteria were used to determine cases of aMCI (Petersen, 2004), according to:
1. Complaints of memory impairment confirmed by others
2. Objective evidence of memory impairment, e.g., memory test (delayed story recall test) scores lower than (age- and duration-) matched healthy controls by 1.5 standard deviations
3. An overall normal level of cognitive function, i.e., impairment is less than dementia level, Clinical Dementia Rating scale point = 0.5
4. Normal daily living skills, according to the Activities of Daily Living scale, mini-mental state examination score of < 26 points
In the normal control (NC) group, criteria are based on capacity for independence, normal findings on neurological examination and mini-mental state examination score of ≥ 28 points.
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients with history of hypertension, diabetes, mental illness, cancer, autoimmune or other diseases, or alcohol or drug abuse
2. Hachinski Ischemic Scale scores more than 4
Recruitment start date
01/06/2010
Recruitment end date
31/12/2017
Locations
Countries of recruitment
China
Trial participating centre
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
No.600, Yishan Road
Shanghai
200233
China
Sponsor information
Organisation
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Sponsor details
No.600
Yishan Road
Shanghai
200233
China
+86 (0)21 64844183
songgp1979@163.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Shanghai Municipal Education Commission - Gaofeng Clinical Medicine in China, No. 2016427
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Clinical Science and Technology Innovation Project of Shanghai Shen Kang Hospital Development Center in China, No. SHDC22015038
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Shanghai Municipal Science and Technology Commission Medical Guide Project in China, No.16411968900
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Guoping Song (songgp1979@163.com).
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list