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Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases

Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06295263
Enrollment
460
Registered
2024-03-06
Start date
2022-03-01
Completion date
2026-06-29
Last updated
2025-05-11

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

Conditions

Alzheimer Disease, Geriatric Diseases, Nervous System Diseases, Parkinson Disease

Keywords

Parkinson Disease, Alzheimer Disease, Nervous System Diseases, geriatric diseases, AI, Deep learning

Brief summary

1\) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease. (2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease. (3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders. (4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients.

Detailed description

1\. Study variables (factors) and measurements 1. All enrolled subjects collected data including general clinical information, PD patients completed motor function assessment and non-motor function assessment, AD patients completed cognitive function assessment and mood-sleep assessment, patients with other neurological disorders perfected disease-related clinical information and scale assessment, and healthy elderly and young controls perfected general clinical information and scale screening. 2. All selected subjects complete handwriting recording, gait assessment, language entry and eye movement recording, and collect biological samples (blood (3 ml/case), urine (3 ml/case), stool (2 g/case), saliva (3 ml/case) and other clinical test results), imaging, EEG and other relevant markers for the study of diagnostic and treatment plan and correlation analysis of AI technology. 1. Motor symptom assessment: UPDRS score 2. Non-motor symptom assessment: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MOCA), Hamilton Anxiety Scale (HAMD), and Hamilton Anxiety Diagnostic Scale (HAD). Hamilton Anxiety Scale (HAMD), Hamilton Depression Scale (HDMD), SF-36. 2\. Sample size 100 patients with primary Parkinson's disease were included, 100 patients with Alzheimer's disease were included, 100 patients with other neurological disorders were included, 80 healthy elderly controls, and 80 healthy young controls. 3 Data collection and management Data collection was firstly collected by applying the paper version of the case report form, and then entered into the computer by a specialized person. 4\. Statistical analysis methods For continuous variables, statistical descriptions were performed using mean ± standard deviation, and for categorical variables, frequency and rate (%) were used. For comparison of parameters between two groups, t-test or rank sum test was used for continuous type variables and chi-square test was used for categorical variables. For one-way correlation analysis, Pearson or Spearman correlation analysis was used. For multifactor analysis, generalized linear model or logistic regression model was used. All of the above parameters were considered statistically significant at p\<0.05. 5\. Quality control 1. Clinical data disease diagnosis: determined by two Parkinson's and movement disorders group deputy chief physicians and above; 2. Scale assessment: adjudicated by two scale-trained neurologists; 3. Statistics: performed by clinical statisticians. 6. Research feasibility analysis Qilu Hospital of Shandong University is a one-stop diagnosis and treatment center for Parkinson's disease and a clinical research center of geriatrics in Shandong Province, with a large patient attendance group and clear clinical significance; our research center is equipped with handwriting analyzer, gait analyzer, speech and eye movement capture analyzer, and has analyzers for collecting biological samples, imaging information and EEG information, which has the basis for further in-depth research.

Interventions

OTHERHandwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers

Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in all experimental and control groups

Sponsors

Shandong University
CollaboratorOTHER
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. Inclusion Criteria 1.1 A total of 100 patients with primary Parkinson's disease were enrolled. The inclusion criteria were as follows: patients with primary Parkinson's disease, based on the 2015 MDS diagnostic criteria for Parkinson's disease. Disorder (MMSE score \< 24); (3) those with severe mental illness who are difficult to cooperate. 1.2 A total of 100 patients with Alzheimer's disease were enrolled. The inclusion criteria were as follows: patients with Alzheimer's disease, based on the IWG-2 clinical diagnostic criteria. 1.3 Neurodegenerative diseases (non-PD and non-AD) group (n = 100) : meeting the diagnostic criteria of the corresponding diseases. 1.4 Eighty healthy elderly controls were included. The inclusion criteria were as follows: ① voluntarily participated in this study and signed the informed consent; ② Age and gender were matched with the case group. 1.5 80 young healthy controls, inclusion criteria: ① voluntarily participated in this study and signed the informed consent; ② Gender was matched with the case group, and the age was less than 60 years old. 2.

Exclusion criteria

2.1 A total of 100 patients with PD were enrolled.

Design outcomes

Primary

MeasureTime frameDescription
Handwriting2022-2~2026-6The patterns and related auxiliary features of patients' handwritten notes were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.
gait2022-2~2026-6The patients' stride length and gait frequency were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.
speech2022-2~2026-6The speech of the patients were collected and analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.
eye movements2022-2~2026-6The eye movement data of the patients were collected and analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.
biological samples (blood, urine, stool, saliva, etc.)2022-2~2026-63-5ml of biological specimens were retained for testing and data analysis
images2022-2~2026-6MRI、MRA、SWI、DTI and other imaging data were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.
EEG2022-2~2026-6Mean frequency, relative power, absolute power, electrode correlation, coherence, time-frequency analysis,etc
other relevant markers2022-2~2026-6Some other markers are waiting to be studied and discovered,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used.

Countries

China

Contacts

Primary ContactJun Ma
majun1228med@163.com18560082039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026