| CTRI Number |
CTRI/2024/07/071749 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Artificial intelligence assisted Model for diagnosing types of dementia in patients with memory loss using MRI data for early and timely treatment. |
|
Scientific Title of Study
|
Artificial Intelligence-assisted Dementia Prediction Model |
| Trial Acronym |
AIDPM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Patkar |
| Designation |
Director of medical services and Head of Imaging |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
MRI,Radiology department,Ground floor,LIC Colony,SV Road,Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
09821136677 |
| Fax |
|
| Email |
drdppatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Patkar |
| Designation |
Director of medical services and Head of Imaging |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
MRI,Radiology department,Ground floor,LIC Colony,SV Road,Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
09821136677 |
| Fax |
|
| Email |
drdppatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Patkar |
| Designation |
Director of medical services and Head of Imaging |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
MRI,Radiology department,Ground floor,LIC Colony,SV Road,Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
09821136677 |
| Fax |
|
| Email |
drdppatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nanavati Max Super Speciality Hospital,LIC Colony,SV Road,Vile Parle (West),Mumbai -400056 ,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Deepak Patkar |
| Address |
MRI,Radiology Department,Ground floor,Nanavati Max Super Speciality Hospital, S.V Road, Vile Parle (West),Mumbai 400056,Maharashtra,India |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Patkar |
Nanavati Max Super Speciality Hospital |
MRI,Radiology department,Ground floor,LIC Colony, S V Road, Vile Parle West,Mumbai-400056
Mumbai (Suburban)
MAHARASHTRA |
9821136677
drdppatkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G309||Alzheimers disease, unspecified, (2) ICD-10 Condition: G310||Frontotemporal dementia, (3) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Be aged 65 years or older
Have a diagnosis of dementia by a specialist (Geriatric, Psychiatrist, or Neurologist)
Have a live-in caregiver
Live in their own homes
|
|
| ExclusionCriteria |
| Details |
Schizophrenia
Memory complaints
Wear a pacemaker
Diagnostic of neurological disorder – stroke, epilepsy, multiple sclerosis, traumatic brain injury, brain tumor
Contraindications to magnetic resonance imaging
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study aims to develop, train and test an AI-assisted model for predicting the type of dementia based on retrospective cross-sectional data. |
5 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Training and testing the model on 500 retrospective patients data |
2 years |
|
|
Target Sample Size
|
Total Sample Size="1625"
Sample Size from India="1625"
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)
|
01/09/2024 |
| 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="6"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This is a retrospective cross-sectional study in which the DICOM images of patients who have undergone dementia protocol of MRI will be used. This DICOM image data will be used to train the predictive model with an aim to predict the diagnosis of dementia and its type based on radiological findings. |