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CompletedNCT06488430Updated Aug 4, 2026

Mild Cognitive Impairment and Multidomain Intervention Package

An observational study in Mild Cognitive Impairment, sponsored by University of Pittsburgh. Completed at 1 site in India. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
50 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 epidemic. The state of Kerala having highest proportion of older adults and burden of lifestyle diseases in India causes even greater concern. Hence, there is need for identifying the burden of mild cognitive impairment, developing a feasible multidomain preventive intervention to be applied among older adults to prevent cognitive decline.

Objectives

  1. To estimate the burden of mild cognitive impairment among community dwelling adults between 50-65 years in a taluk of a South Kerala district
  2. To develop a multidomain intervention package for preventing cognitive decline in those with mild cognitive impairment

2. To explore the barriers and facilitators for adherence towards multidomain intervention to prevent cognitive decline in community dwelling older adults between 50- 65 years with mild cognitive impairment in the study area Recruitment: The sampling area consists of 54 wards (39 rural and 15 urban) from Tiruvalla Taluk of Pathanamthitta district. A ward is a division of the community at the local government level with approximately 300-500 families and an elected government representative from the community known as ward member. From these wards, 15 rural and 5 (total 20 wards) urban wards will be randomly picked. From each ward, 24 eligible participants will be randomly picked from all the wards, one extra person from the last ward in order to reach the sample size. ASHA workers will help the team to identify the eligible candidates. The ASHA workers and the ward members will communicate to the community regarding the study which would help the research team to build a rapport with the community. The research team will explain the details of the study and consent form to the potential participants. Identified, consented adults (50- to 65-year-old) will be screened using the study tool to identify those with mild cognitive impairment.

Screening: All individuals (50-65yrs) consenting to participate will be included. Those who are unable to respond, critically ill and with a diagnosis of dementia (physician diagnosed) will be excluded. MCI in the study will be assessed using the European Alzheimer's Disease Consortium. Participants who meet all the five criteria of this definition will be defined as MCI cases.

Enrollment: Twenty participants found to have MCI will be enrolled in to a pilot study to explore the barriers and facilitators of adherence towards the intervention package. The inclusion and exclusion criteria has been detailed earlier. All those with MCI from a ward will be included. If adequate number is not available in a ward, rest of the participants will be taken from the adjacent ward.

Intervention: A multidomain intervention will be developed and will be pilot tested for adherence for a period of one month. The intervention includes nutritional advice, physical activity, cognitive stimulation therapy, social engagements and, management of vascular risk factors.

Assessment The cognitive ability, depression, activities of daily living, quality of life will be assessed during the screening phase by using standard questionnaires validated in the local language. The adherence towards the individual and group activities in the intervention will be assessed using checklists. In-depth interviews will be conducted to understand the barriers and facilitators towards adherance.

Followup The research team will assess the adherence towards intervention using checklists. In depth interviews will be done to identify the barriers and facilitators towards adherence.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Dementia
  • cognitive ability
  • Mild cognitive impairment (MCI)
  • Multidomain intervention
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 20 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralMultidomain intervention package for preventing cognitive decline

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Six months

  2. Facilitators for participation and adherence

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

    Time frame: Baseline and after intervention

07

Study locations

1 site
  • Believers Church Medical College
    Tiruvalla, Kerala 689 103, India
08

References and documents

Study documents

  • Study protocol · Jul 28, 2023
  • Informed consent form · Jul 28, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06488430
Lead sponsor
University of Pittsburgh
Collaborators
Fogarty International Center of the National Institute of Health, Believers Church Medical College Hospital, Tiruvalla, Kerala, India
Responsible party
Vishwajit Nimgaonkar, MD PhD (Professor, University of Pittsburgh) — Principal investigator
First posted
Jul 5, 2024
Start date
Apr 15, 2024
Primary completion
Jan 31, 2026
Completion
Feb 20, 2026
Last update
Aug 4, 2026

Study contacts

Vishwajit L Nimgaonkar, MD,
principal investigator · university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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