Status:

COMPLETED

Mild Cognitive Impairment and Multidomain Intervention Package

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

Fogarty International Center of the National Institute of Health

Believers Church Medical College Hospital, Tiruvalla, Kerala, India

Conditions:

Dementia

Eligibility:

All Genders

50-65 years

Phase:

NA

Brief Summary

The state of Kerala, India has the highest proportion of older adults and the burden of lifestyle diseases causes great concern. Therefore, there is need for identifying a feasible multidomain prevent...

Detailed Description

In the context of increasing older adults, the burden of dementia is forecasted to increase in India. Interventions targeting risk factors and diseases may be the key element to counter the dementia e...

Eligibility Criteria

Inclusion

  • Phase 1- All individuals (50-65yrs) consenting to participate will be included. Phase 3- Inclusion for multidomain intervention
  • Individuals between 50-65 years old, willing to participate and comply with all the study evaluation and intervention procedures
  • CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of 6 points or higher
  • Those identified to have mild cognitive impairment in phase 1 screening

Exclusion

  • • Phase 1- Those who are unable to respond, critically ill and having a physician diagnosed dementia report will be excluded.
  • Phase 3- Exclusion for multidomain intervention
  • Geriatric Depression Scale ≥ 9
  • Dementia
  • Disorders that may affect safe involvement in the intervention (eg, malignancy, symptomatic cardiovascular disease, Large vessel stroke in the past two years, History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months, revascularization within 1 year previously, severe loss of vision, hearing, or communicative ability)
  • Coincident participation in another intervention trial.
  • Recent (\< 3 months) bone fracture.
  • History of hip fracture, joint replacement, or spinal surgery in the last 6 months
  • Clinically significant abnormalities in laboratory blood tests as per judgment of the site study clinician.

Key Trial Info

Start Date :

June 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2025

Estimated Enrollment :

481 Patients enrolled

Trial Details

Trial ID

NCT06488430

Start Date

June 15 2024

End Date

September 30 2025

Last Update

December 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Believers Church Medical College

Tiruvalla, Kerala, India, 689 103

Mild Cognitive Impairment and Multidomain Intervention Package | DecenTrialz