Condition category
Nervous System Diseases
Date applied
18/03/2019
Date assigned
08/04/2019
Last edited
04/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

01/04/2019: Trial's existence confirmed by the Ethics Review Board of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.