Clinical trial NCT03119051: Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
Official title: Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Keywords: mild cognitive impairment
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Huashan Hospital
First posted: 2017-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.

Detailed description: Mild cognitive impairment (MCI) is an early stage of Alzheimer Disease (AD). Increasing evidence has indicated that cognitive trainings improve cognition functions of MCI patients in multiple cognitive domains, making it a promising therapy for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent of its function in reducing the conversion rate from MCI to AD.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 50-85;
* MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups\[1\];
* 24≤Mini-Mental State Examination (MMSE) ≤28；
* The Hamilton Depression Scale/17-item (HAMD) score ≤10;
* Not on medication for dementia;
* MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; \>70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.
* Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
* Education level: primary school (grade 6) or above.
* Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.

Exclusion Criteria:

* Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
* Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
* Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
* Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
* History of alcohol or drug abuse;
* Participation in other clinical trial less than 30 days before the screening of this study;
* Inability to complete the study.

Primary outcomes:
measure: Incidence of AD
timeFrame: 12 months
Secondary outcomes:
measure: The global cognitive function of MCI patients
timeFrame: 6 months
measure: Memory
timeFrame: 12 months
measure: Attention
timeFrame: 12 months
measure: Executive functions
timeFrame: 12 months
measure: Language
timeFrame: 12 months
measure: Visual spatial ability and visual memory
timeFrame: 12 months
measure: Activities of daily living
timeFrame: 6 months
measure: Structural MRI
timeFrame: 12 months
measure: Gut microbiota
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Sheng-Di Chen
role: STUDY_DIRECTOR
References:
citation: Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.