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AzTrials

Parkinson DiseaseNCT06295263

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

An observational study of Parkinson Disease and Alzheimer Disease, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 100 yearsHealthy volunteers can take part
What is being tested?
Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
How many people
460 participants
Where
1 siteChina
Study dates
1 Mar 2022to 29 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 1. 100 patients with primary Parkinson's disease were included, mainly from the outpatient clinics and wards of the Parkinson's Disease and Movement Disorders Center. Inclusion criteria: patients with primary Parkinson's disease, based on the 2015 MDS Parkinson's disease diagnostic criteria. 2. 100 patients with Alzheimer's disease were included, mainly from geriatric neurology outpatient clinics and wards (F5A\&F6A). Inclusion criteria: patients with Alzheimer's disease, meeting the IWG-2 clinical diagnostic criteria as the basis. 3. Neurodegenerative diseases (non-PD and non-AD) group 100 people: the source of neurology outpatient clinic 4. 80 healthy elderly controls, from peer attendees and health check centers. 5. 80 young healthy controls, from peer clinic attendees and health screening centers.

  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. Exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and after neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); (3) those with severe mental illness who are difficult to cooperate.

2.2 A total of 100 patients with Alzheimer's disease were enrolled. The exclusion criteria were: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate.

2.3 Neurodegenerative diseases (non-PD non-AD) group (n = 100), exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate.

2.4 Eighty healthy elderly controls were included. The exclusion criteria were as follows: ① History of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance.

2.5 80 young healthy controls, exclusion criteria: ① history of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgical surgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Wenjing Jiang, 18560082210, jiangwenjing@qiluhospital.com

    Recruiting

Other trials in China

About this study

  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.
Read the detailed description
  1. Study variables (factors) and measurements
  2. 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.
  3. 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.
  4. Motor symptom assessment: UPDRS score
  5. 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.
  6. 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.
  7. 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.
  8. Quality control
  9. Clinical data disease diagnosis: determined by two Parkinson's and movement disorders group deputy chief physicians and above;
  10. Scale assessment: adjudicated by two scale-trained neurologists;
  11. 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.
Being tested
Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
Keywords
Parkinson Disease, Alzheimer Disease, Nervous System Diseases, geriatric diseases, AI, Deep learning
Medical subject headings
Parkinson Disease, Alzheimer Disease, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT06295263
Study groupRoleWhat they receive
Parkinson Disease group100 patients with primary Parkinson's disease were included, mainly from outpatient clinics and wards of the Parkinson's Disease and Movement Disorders Center. Inclusion criteria: patients with primary Parkinson's disease, based on the 2015 MDS Parkinson's disease diagnostic criteria. Exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and postoperative neurosurgery; ② patients with various types of cognitive disorders (MMSE score <24); ③ severe psychiatric disorders that are difficult to cooperate.
Receives: Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
Alzheimer Disease groupOne hundred patients with Alzheimer's disease were included, mainly from geriatric neurology outpatient clinics and wards (F5A \& F6A). Inclusion criteria: patients with Alzheimer's disease, meeting the IWG-2 clinical diagnostic criteria as the basis. Exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and postoperative neurosurgery; ② severe psychiatric illnesses that are difficult to cooperate with.
Receives: Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
Nervous System Diseases groupNeurodegenerative diseases (non-PD non-AD) group 100: source neurology outpatient clinic visits, exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and neurosurgery postoperative; ② severe psychiatric diseases difficult to cooperate with the person.
Receives: Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
Healthy geriatric groupHealthy elderly control 80 people, from peer attendees and health checkup centers. Inclusion criteria: ① Voluntary participation in this study and signing of informed consent; ② Age and gender matched with the patients in the case group; Exclusion criteria: ① Previous history of chronic diseases related to the study subjects, such as cerebrovascular disease, traumatic brain injury, inflammatory diseases of the central system, intracranial tumors and neurosurgery, etc.; ② Patients with various types of cognitive disorders (MMSE scores <24); ③ Those with poor adherence.
Receives: Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
Healthy Adults GroupYoung healthy controls 80 people, from peer attendees and health screening centers. Inclusion criteria: ① Voluntary participation in the study and signing of informed consent; ② Gender matched with the patients in the case group, age <60 years; Exclusion criteria: ① History of chronic diseases related to the study subjects, such as cerebrovascular disease, traumatic brain injury, inflammatory diseases of the central system, intracranial tumors and neurosurgery, etc.; ② With various types of cognitive disorders (MMSE scores <24); ③ Poor adherence to the study. Poor adherence.
Receives: Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Handwriting

    The 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.

    Measured: 2022-2~2026-6

  2. gait

    The 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.

    Measured: 2022-2~2026-6

  3. speech

    The 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.

    Measured: 2022-2~2026-6

  4. eye movements

    The 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.

    Measured: 2022-2~2026-6

  5. biological samples (blood, urine, stool, saliva, etc.)

    3-5ml of biological specimens were retained for testing and data analysis

    Measured: 2022-2~2026-6

  6. images

    MRI、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.

    Measured: 2022-2~2026-6

  7. EEG

    Mean frequency, relative power, absolute power, electrode correlation, coherence, time-frequency analysis,etc

    Measured: 2022-2~2026-6

  8. other relevant markers

    Some 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.

    Measured: 2022-2~2026-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Mar 2022
  3. Primary completion28 Jun 2026 (estimated)
  4. Study completion29 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295263
Sponsor's protocol ID
KYLL-202203-028-1
Status last verified
Apr 2025
First submitted
17 Feb 2024
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Alzheimer Disease, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Ma (18560082039, majun1228med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Handwriting (time frame: 2022-2~2026-6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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