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

Not Applicable

Completed

• Conditions: Alzheimer’s disease, amnestic mild cognitive impairment, normal aging; Nervous System Diseases; Alzheimer disease

• Registration Number: ISRCTN17337128
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31397353/ (added 02/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-31
• Study Start: 2019-04-08
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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