Mild Cognitive Impairment and Multidomain Intervention Package

NCT06488430 | Completed

• 2 other identifiers: STUDY230100155D43TW009114-10
• Study Type: interventional
• Target: 481
• 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

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Attention domain of Addenbrooke's Cognitive Examination-III (ACE-III).

  Change in attention domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the cognitive domains assessed. \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18. )

  Baseline, After one month intervention

• Memory domain of Addenbrooke's Cognitive Examination-III (ACE-III).

  Change in memory domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 26. )

  Baseline, After one month intervention

• Fluency domain of Addenbrooke's Cognitive Examination-III (ACE-III).

  Change in fluency domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 14. \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18. )

  Baseline, After one month intervention

• Language domain of Addenbrooke's Cognitive Examination-III (ACE-III).

  Change in language domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 26. \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18. )

  Baseline, After one month intervention

• Visuospatial domain of Addenbrooke's Cognitive Examination-III (ACE-III).

  Change in visuospatial domain scores of Malayalam version of Addenbrooke's Cognitive Examination (m-ACE) will be tested after intervention (Score below the cut-off in at least one of the domains tested. The lowest score is 0 and highest score is 16. \[One SD below the mean score (of that educational category) was taken as the cut-off for each domain\] The minimum score is 0 and maximum score is 18. )

  Baseline, After one month intervention

Secondary Outcomes (1)

• Depression score on Geriatric Depression Scale

  Baseline and after one month intervention

Study Arms (1)

Multidomain intervention package for preventing cognitive decline

EXPERIMENTAL

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.

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+)

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

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Vishwajit L Nimgaonkar, MD,

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Mixed-Methods study Phase 1: Quantitative design to assess the burden of mild cognitive impairment (MCI) Phase 2: Development of multidomain intervention (DONE) Phase 3: Qualitative design to explore the barriers and facilitators for adherence to intervention

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 5, 2024
• Study Start: June 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

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)