| CTRI Number |
CTRI/2024/09/073471 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
P-CARRS-BRAIN: Multi-domain risk factors and prediction of Alzheimers Disease
in South Asian Indians |
|
Scientific Title of Study
|
P-CARRS-BRAIN: Multi-domain (genetic, socio-behavioral, vascular) risk factors and prediction of Alzheimer’s Disease continuum in South Asians in India (P-CARRS Brain Study). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof D Prabhakaran |
| Designation |
Executive Director |
| Affiliation |
Centre for Chronic Disease Control |
| Address |
Centre for Chronic Disease Control, Executive Director, 4th Floor, Plot # 47 Sector-44, NCR Gurgaon
Gurgaon
HARYANA
122022
India |
| Phone |
9810118696 |
| Fax |
|
| Email |
dprabhakaran@ccdcindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof D Prabhakaran |
| Designation |
Executive Director |
| Affiliation |
Centre for Chronic Disease Control |
| Address |
Centre for Chronic Disease Control, Exceutive Director, 4th Floor, Plot # 47 Sector-44, NCR Gurgaon
Gurgaon
HARYANA
122022
India |
| Phone |
9810118696 |
| Fax |
|
| Email |
dprabhakaran@ccdcindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sailesh Mohan |
| Designation |
Deputy Director and Head CVD Epidemiology unit |
| Affiliation |
Centre for Chronic Disease Control (CCDC) |
| Address |
Centre for Chronic Disease Control, Head, CVD epidemiology unit 4th Floor, Plot # 47 Sector-44, NCR Gurgaon
Gurgaon
HARYANA
122022
India |
| Phone |
9650335597 |
| Fax |
|
| Email |
smohan@ccdcindia.org |
|
|
Source of Monetary or Material Support
|
| National Institute on Aging (NIA) under the National Institute of Health (NIH) -funded Alzheimers Disease Research Centers |
|
|
Primary Sponsor
|
| Name |
National Institute on Aging (NIA) under the National Institute of Health, USA |
| Address |
National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Prabhakaran |
Centre for Chronic Disease Control (CCDC) |
Executive Director, CVD division, 4th Floor, Plot # 47 Sector-44, NCR Gurgaon
Gurgaon
HARYANA |
9810118696
dprabhakaran@ccdcindia.org |
| Dr Viswanathan Mohan |
Madras Diabetes Research Foundation (MDRF) |
Chairman, No. 6B, Conran Smith Road, Gopalapuram,Chennai 600 086
Chennai
TAMIL NADU |
9840097370
drmohans@diabetes.ind.in |
| Dr Suvarna Alladi |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Professor & Head, Department of Neurology, #2900, Nimhans Building, Lakkasandra Hombegowda Nagar
Bangalore
KARNATAKA |
8026995994
alladisuvarna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Centre for Chronic Disease Control (CCDC) |
Approved |
| Madras Diabetes Research Foundation (MDRF) |
Approved |
| National Institute of Mental Health and Neurosciences (NIMHANS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (3) ICD-10 Condition: I10||Essential (primary) hypertension, (4) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, (5) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (6) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 40 years and more at baseline living in the urban areas of Delhi and Chennai |
|
| ExclusionCriteria |
| Details |
Pregnant women and bed-ridden individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In preliminary studies, it has successfully demonstrated the feasibility of administering novel AI-enabled digital cognitive assessment tools, collecting and processing plasma AD biomarkers, and pilot standardization of MRI neuroimaging biomarkers. This study will advance progress in understanding the natural history of the AD/ADRD along the life course and promote early detection, precise diagnosis and tailored therapeutic strategies for this high-risk, understudied population and beyond. |
This study is a 5 year observational cohort study; so the outcome will be assessed after the completion of five years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="8142"
Sample Size from India="8142"
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)
|
01/01/2025 |
| 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="5"
Months="0"
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 study aims to enhance the understanding of Alzheimer’s Disease (AD) and the related diseases continuum (ADRD) starting in midlife. It seeks to identify novel risk factors and enable accurate disease prediction within the Precision CARRS cohort. The study will be conducted at two sites: CCDC (Delhi) and MDRF (Chennai), focusing on characterizing risks and outcomes in individuals who were enrolled in CARRS in two waves (2010, 2015) at ages ≥40 years. |