NCT06295263

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2022Jun 2026

Study Start

First participant enrolled

March 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

February 17, 2024

Last Update Submit

May 6, 2025

Conditions

Keywords

Parkinson DiseaseAlzheimer DiseaseNervous System Diseasesgeriatric diseasesAIDeep learning

Outcome Measures

Primary Outcomes (8)

  • 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.

    2022-2~2026-6

  • 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.

    2022-2~2026-6

  • 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.

    2022-2~2026-6

  • 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.

    2022-2~2026-6

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

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

    2022-2~2026-6

  • 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.

    2022-2~2026-6

  • EEG

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

    2022-2~2026-6

  • 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.

    2022-2~2026-6

Study Arms (5)

Parkinson Disease group

100 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.

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

Alzheimer Disease group

One 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.

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

Nervous System Diseases group

Neurodegenerative 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.

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

Healthy geriatric group

Healthy 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.

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

Healthy Adults Group

Young 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.

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

Interventions

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

Alzheimer Disease groupHealthy Adults GroupHealthy geriatric groupNervous System Diseases groupParkinson Disease group

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Neurodegenerative diseases (non-PD and non-AD) group (n = 100) : meeting the diagnostic criteria of the corresponding diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

lood, urine, stool, saliva, etc

MeSH Terms

Conditions

Parkinson DiseaseAlzheimer DiseaseNervous System Diseases

Interventions

GaitEye MovementsBlood Specimen CollectionUrinationDefecation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDementiaTauopathiesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological PhenomenaSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2024

First Posted

March 6, 2024

Study Start

March 1, 2022

Primary Completion (Estimated)

June 28, 2026

Study Completion (Estimated)

June 29, 2026

Last Updated

May 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations