Differentiating Alzheimer’s disease, amnestic mild cognitive impairment and normal aging

ISRCTN ISRCTN17337128
DOI https://doi.org/10.1186/ISRCTN17337128
Secondary identifying numbers 1.0
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Guoping Song
Public

No.600, Yishan Road
Shanghai
200233
China

Phone +86 (0)21 64844183
Email songgp1979@163.com

Study information

Study designCross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Scientific titleDifferentiating Alzheimer’s disease, amnestic mild cognitive impairment and normal aging using diffusion kurtosis imaging parameters
Study objectivesTo 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) studiedAlzheimer’s disease, amnestic mild cognitive impairment, normal aging
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureMean 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 measuresMean 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 study start date01/01/2010
Completion date31/12/2018

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaThe 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 criteria1. 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 enrolment01/06/2010
Date of final enrolment31/12/2017

Locations

Countries of recruitment

  • China

Study participating centre

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
No.600, Yishan Road
Shanghai
200233
China

Sponsor information

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Hospital/treatment centre

No.600, Yishan Road
Shanghai
200233
China

Phone +86 (0)21 64844183
Email songgp1979@163.com
ROR logo "ROR" https://ror.org/049zrh188

Funders

Funder type

Government

Shanghai Municipal Education Commission - Gaofeng Clinical Medicine in China, No. 2016427

No information available

Clinical Science and Technology Innovation Project of Shanghai Shen Kang Hospital Development Center in China, No. SHDC22015038

No information available

Shanghai Municipal Science and Technology Commission Medical Guide Project in China, No.16411968900

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe 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.