| CTRI Number |
CTRI/2025/11/098009 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A smart computer system that helps predict memory, thinking ability, and daily functioning in middle-aged and older adults. |
|
Scientific Title of Study
|
Deep Learning Predictive Model for Cognitive and Functional Status among Middle-aged and Elderly Population |
| Trial Acronym |
DEEP-COG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Dogra |
| Designation |
Associate Professor |
| Affiliation |
Chitkara University, Rajpura |
| Address |
Chitkara School of Health Science, Chitkara University Rajpura
Patiala PUNJAB 140401 India |
| Phone |
9478606063 |
| Fax |
|
| Email |
pooja.dogra@chitkara.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Pooja Dogra |
| Designation |
Research Scholar |
| Affiliation |
Chitkara University, Rajpura |
| Address |
Chitkara University Rajpura
Patiala PUNJAB 140401 India |
| Phone |
9478606063 |
| Fax |
|
| Email |
pooja.dogra@chitkara.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Chand Rani |
| Designation |
Research Scholar |
| Affiliation |
Chitkara University, Rajpura |
| Address |
Chitkara University Rajpura
Patiala PUNJAB 140401 India |
| Phone |
9478606063 |
| Fax |
|
| Email |
drchandsharma1698@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Chand Rani |
India (Community) |
Chitkara University Rajpura Patiala PUNJAB |
09478606063
chand.rani@chitkara.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee Chitkara University Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participate with the age of 44 to 75 with no neurological and psychological condition. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
44.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 44–75 years (middle-aged 44–60; elderly 60–75) who are medically stable, able to provide informed consent, and capable of face-to-face assessments with sufficient cognitive awareness to understand the evaluation tools will be included. |
|
| ExclusionCriteria |
| Details |
Have a diagnosed neurodegenerative condition (e.g., Alzheimer’s disease, Parkinson’s disease)
Suffer from severe psychiatric disorders or intellectual disabilities
Have hearing, vision, or communication impairments that may interfere with assessment
Are currently hospitalized or undergoing acute medical treatment
Are unwilling or unable to comply with the study protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognition- Montreal Cognitive Assessment
Functional- Barthel Index, Lawton-IADL scale |
During assessment as it is observational study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="346" Sample Size from India="346"
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)
|
10/12/2025 |
| 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="0" Months="6" Days="0" |
|
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 observational cross-sectional study aims to assess cognitive and functional status in adults aged 44–75 years using standardized assessment tools. The study will also develop a deep learning model to predict cognitive performance based on demographic and clinical variables. Findings may support early identification of individuals at risk of cognitive decline and guide future screening approaches. |