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Prevention of Dementia in elderly Indians (SMRUTHI-INDIA)

Strategic Multimodal Intervention in at-risk elderly Indians for Prevention of Dementia (SMRUTHI-INDIA): A cohort multiple randomised controlled trial (cmRCT) - SMRUTHI-INDIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061172
Enrollment
10000
Registered
2024-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Multimodal care bundle: Multimodal care bundle constitutes of regular monitoring of vascular risk factors, culturally appropriate nutritional guidance, physical exercise/yoga, and psych

Sponsors

Department of Health Research,ICMR,MOHFW, ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than or equal to 55 years 2. Permanent resident of the defined area 3. CAIDE (Cardiovascular Risk Factors Aging and Dementia) Risk Score of 6 points or higher 4. Absence of Dementia or MCI (DSM 5 criteria for major Neurocognitive Decline) after Neuropsychological evaluation 5. Consenting to participate and complete all study related activities for 5 years

Exclusion criteria

Exclusion criteria: 1. Established Dementia 2. Disabling stroke or structural brain abnormality 3. Vision, hearing or communication impairment affecting NP testing 4. Psychiatric illness- major depressive disorder, psychosis 5. Significant medical illness like malignancy, end stage renal disease, decompensated liver disease

Design outcomes

Primary

MeasureTime frame
Incidence of all cause probable dementia or mild cognitive impairmentTimepoint: 5 years

Secondary

MeasureTime frame
Change in composite and domain Z scoresTimepoint: 5 years;Change in LIBRA IndexTimepoint: 5 years;Composite outcome of stroke and MITimepoint: 5 YEARS;Composite outcome of stroke, MI, MCI, DementiaTimepoint: 5 years;Incidence of mild cognitive impairmentTimepoint: 5 years;MortalityTimepoint: 5 years;time to first occurrence of diagnosis of dementiaTimepoint: 5 years;time to first occurrence of diagnosis of MCITimepoint: 5 YEARS

Countries

India

Contacts

Public ContactVishnu VY

AIIMS New Delhi

vishnuvy16@yahoo.com9855480361

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026