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A prospective, single site, evaluator blind, randomized controlled clinical trial to evaluate the effectiveness and safety of customized linked memory game training and rehabilitation software in subjects with mild and moderate Alzheimer's disease

A prospective, single site, evaluator blind, randomized controlled clinical trial to evaluate the effectiveness and safety of customized linked memory game training and rehabilitation software in subjects with mild and moderate Alzheimer's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063185
Enrollment
Unknown
Registered
2022-09-01
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild and moderate Alzheimer's disease

Interventions

Experimental group:Customized linked memory game rehabilitation training software treatment, twice a day (once in the morning and once in the afternoon), each training time is 30 ± 5 minutes, 5 days a
Control group:Cognitive function training under the guidance of rehabilitation therapist, twice a day, each training time is 30 ± 5 minutes, 5 days a week, a total of 4 weeks

Sponsors

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, subjects aged 60 to 85 years (inclusive) at the time of screening; 2. Willing and able to provide informed consent, provided by or legally authorized representative; 3. Have the listening, speaking, reading, writing and language skills required to participate in all tests; 4. Have a study partner/caregiver who can supervise and assist subjects with cognitive training games on a daily basis, and have in-depth knowledge of subjects' cognitive, functional and emotional states and personal care. The study partner must be willing to accompany the subject on all study visits, ensure that all medications and cognitive training are effectively administered, and report adverse events; 5. Meet the diagnostic criteria for dementia.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of non-AD central nervous system diseases associated with dementia (e.g., Parkinson's disease, Huntington's disease, frontotemporal dementia, dementia with multiple cerebral infarction, dementia with Lewy bodies, normal cranial pressure hydrocephalus); 2. History of folic acid, thyroid, and/or vitamin B12 abnormalities that could not be corrected prior to baseline visit; 3. For major structural encephalopathy diagnosed by MRI in the past (such as ischemic infarction, subdural hematoma, hemorrhage, hydrocephalus, brain tumor, multiple subcortical ischemic lesions or single lesions in key areas (such as thalamus)), if MRI examination is not possible (about 10% of subjects at most), computed tomography (CT) scan can replace the MRI examination standard; 4. Psychiatric disorders identified according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-?) criteria that are unstable within 12 months or would interfere with study evaluation, including schizophrenia or other psychiatric disorders, bipolar disorder, major depression, or delirium; 5. A history of severe arrhythmia, myocardial infarction, transient ischemic attack or cerebrovascular accident, and decompensated congestive heart failure within the past 6 months; 6. The investigator determined that during the 6 months prior to screening, the subject had a major medical condition or unstable medical condition that would interfere with the subject's compliance with study procedures and study restrictions, or with the interpretation of safety data, including any physical disability that might interfere with the completion of study procedures or evaluations (e.g., blindness, hearing loss, non-AD related speech disorders, sensory or motor dysfunction).

Design outcomes

Primary

MeasureTime frame
Senile Dementia Rating Scale-Cognitive Subscale;Mini-mental State Examination;Montreal Cognitive Assessment Scale;Clinical Dementia Rating Scale;

Secondary

MeasureTime frame
Functional Activity Questionnaire Score;Rey Auditory Word Learning;Logical Memory;Boston Naming Test;Voice/Semantic Word Fluency Test;Digit Span Test;Trail Making Test A and B;Hamilton Anxiety Scale (HAMA);Hamilton Depression Scale Score;Pittsburgh Sleep Quality Index;

Countries

China

Contacts

Public ContactJin Lingjing

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

lingjingjin@163.com+86 150 2131 2377

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026