Differentiating Alzheimer’s disease, amnestic mild cognitive impairment and normal aging
| ISRCTN | ISRCTN17337128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17337128 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1.0 |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People’s Hospital |
| Funders | Shanghai Municipal Education Commission - Gaofeng Clinical Medicine in China, No. 2016427, Clinical Science and Technology Innovation Project of Shanghai Shen Kang Hospital Development Center in China, No. SHDC22015038, Shanghai Municipal Science and Technology Commission Medical Guide Project in China, No.16411968900 |
- Submission date
- 18/03/2019
- Registration date
- 08/04/2019
- Last edited
- 02/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Public
No.600, Yishan Road
Shanghai
200233
China
| Phone | +86 (0)21 64844183 |
|---|---|
| songgp1979@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional study |
| Secondary study design | Cross sectional study |
| Scientific title | Differentiating Alzheimer’s disease, amnestic mild cognitive impairment and normal aging using diffusion kurtosis imaging parameters |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Mean kurtosis measured by a 3.0T magnetic resonance scanner (MAGETOM, Verio, Siemens Healthcare, Erlangen, Germany), with a 32-channel head coil after hospitalization |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200233
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Guoping Song (songgp1979@163.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2019 | 02/03/2022 | Yes | No |
Editorial Notes
02/03/2022: Publication reference added.
01/04/2019: Trial's existence confirmed by the Ethics Review Board of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.
