Mild Cognitive Impairment and Multidomain Intervention Package

NCT06488430 | Completed

• 2 other identifiers: STUDY230100155D43TW009114-10
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 preventive intervention to ease this burden. Initially the burden of mild cognitive impairment will be determined as this information is scarce from the setting. A multidomain intervention package will be developed that is appropriate for the setting. The adherence rates, barriers and facilitators will be assessed. If the multidomain intervention is found feasible, it can be recommended for further clinical trials.

Conditions

Mild Cognitive Impairment

Keywords

Dementia; cognitive ability; Mild cognitive impairment (MCI); Multidomain intervention

Outcome Measures

Primary Outcomes (2)

• Prevalence and types of mild cognitive impairment

  To estimate the burden of mild cognitive impairment among community-dwelling adults between 50 and 65 years in a taluk of a South Kerala district

  Six months

• Facilitators for participation and adherence

  The multidomain intervention will be pilot tested in 2 wards, one rural and one urban.

  Baseline and after intervention

Study Arms (1)

Intervention Group for Multidomain intervention package for preventing cognitive decline

A multidomain intervention including nutritional advice, physical activity, cognitive stimulation training, social support and engagement and management of vascular risk factors.

Behavioral: Multidomain intervention package for preventing cognitive decline

Interventions

Multidomain intervention package for preventing cognitive decline BEHAVIORAL

Participants with mild cognitive impairment will be identified and they will participate in a pilot study for one-month duration. During pilot study they will be subjected to a multidomain intervention including nutritional advice, physical activity, cognitive stimulation training, social support and engagement and management of vascular risk factors.

Intervention Group for Multidomain intervention package for preventing cognitive decline

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population were adults between 50-65 years of age with mild cognitive impairment. They belonged to Tiruvalla Taluk of District Pathanamthitta, Kerala, India. Both males and females were selected.

You may qualify if:

• 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

You may not qualify if:

• Phase 1- Those who are unable to respond, critically ill and having a physician diagnosed dementia report will be excluded.
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Believers Church Medical College Hospital, Tiruvalla, Kerala, India: collaborator

Study Sites (1)

Believers Church Medical College

Tiruvalla, Kerala, 689 103, India

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vishwajit L Nimgaonkar, MD,

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 5, 2024
• Study Start: April 15, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 20, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)