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CTRI Number  CTRI/2024/10/076050 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Alzheimer s Insights through MRI Correlation and AI Enhanced Radiologist Evaluation 
Scientific Title of Study   API Module to prediction of Alzheimer s Disease through Al Enhanced Assessment of MRI brain Correlating with Expert Radiologist Reporting 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharmeela S 
Designation  Resident in Radiology 
Affiliation  Saveetha Institute of Medical And Technical Sciences 
Address  no 50 department of radiology Saveetha Nagar Thandalam Kanchipuram Chennai Rd Chennai Tamil Nadu 602105

Chennai
TAMIL NADU
602105
India 
Phone  9486167715  
Fax    
Email  sharmeelarajsantan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arunthathy G 
Designation  PROFESSOR in Radiology 
Affiliation  Saveetha Institute of Medical And Technical Sciences 
Address  no 50 department of radiology Saveetha Nagar Thandalam Kanchipuram Chennai Rd Chennai Tamil Nadu 602105

Chennai
TAMIL NADU
602105
India 
Phone  7299966456  
Fax    
Email  GNANESHWARANETOR8@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  Sharmeela S 
Designation  Resident in Radiology 
Affiliation  Saveetha Institute of Medical And Technical Sciences 
Address  no 50 department of radiology Saveetha Nagar Thandalam Kanchipuram Chennai Rd Chennai Tamil Nadu 602105


TAMIL NADU
602105
India 
Phone  9486167715  
Fax    
Email  sharmeelarajsantan@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 
 
Primary Sponsor  
Name  sharmeela s  
Address  no 50 department of radiology Saveetha Nagar Thandalam Kanchipuram Chennai Rd Chennai Tamil Nadu 602105 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmeela S  Saveetha Institute of Medical And Technical Sciences  no 50 department of radiology Saveetha Nagar Thandalam Kanchipuram Chennai Rd Chennai Tamil Nadu 602105
Chennai
TAMIL NADU 		 09486167715

sharmeelarajsantan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G300||Alzheimers disease with early onset,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  API Module to prediction of Alzheimer s Disease through Al Enhanced Assessment of MRI brain Correlating with Expert Radiologist Reporting  nil 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Participants must be adults aged 55 years and older diagnosed with mild dementia.Participants must have had a recent MRI scan . Participants from various ethnic and demographic backgrounds . 
 
ExclusionCriteria 
Details  Individuals younger than 35 years old.Individuals with conditions that contraindicate the use of MRI (e.g., certain implanted medical devices, severe claustrophobia) or those who are pregnant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to predict Alzheimer s Disease through Al Enhanced
Assessment of MRI brain Correlating with Expert Radiologist Reporting 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the accuracy & clinical utility of the AI
by correlating the expert radiologist s reporting 		 1 week 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharmeelarajsantan@gmail.com].

  6. For how long will this data be available start date provided 02-02-2025 and end date provided 02-04-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

API module to Prediction of Alzheimers Disease through AI-Enhanced Assessment of MRI brain,Correlating with expert radiologist reporting.

Alzheimer’s disease is a progressive neurodegenerative disorder with a significant global impact. Early and accurate diagnosis is crucial for effective management and treatment. A method for predicting Alzheimer’s disease , to accurately assess hippocampus volume and  to  assess cortical atrophy using AI algorithms from MRI brain.Algorithms are trained on large datasets of MRI images and clinical outcomes, The invention entails the development of an API module designed to predict Alzheimer’s disease (AD) through AI-enhanced assessment of MRI brain scans, with a focus on correlating these predictions with expert radiologist reporting.The API module interfaces with MRI imaging devices to receive and pre process MRI brain imaging data. This data serves as the input for subsequent analysis.Furthermore, the API module facilitates research and development efforts in the field of AD diagnosis and neuroimaging, offering a standardized and comprehensive approach to disease prediction. Overall, the invention represents a significant advancement in the early detection and management of Alzheimer’s disease, with potential applications in clinical practice, research, and development.




 
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