Mild Cognitive ImpairmentNCT06488430
Mild Cognitive Impairment and Multidomain Intervention Package
An observational study of Mild Cognitive Impairment, run by University of Pittsburgh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Multidomain intervention package for preventing cognitive decline
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2024to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mild Cognitive Impairment Among Community Dwelling Adults: Prevalence, Associated Factors, and Feasibility of a Multidomain Intervention Package for Preventing Cognitive Decline
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
- To estimate the burden of mild cognitive impairment among community dwelling adults between 50-65 years in a taluk of a South Kerala district
- To develop a multidomain intervention package for preventing cognitive decline in those with mild cognitive impairment
- 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Multidomain intervention package for preventing cognitive decline
- Keywords
- Dementia, cognitive ability, Mild cognitive impairment (MCI), Multidomain intervention
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain intervention package for preventing cognitive declineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multidomain intervention package for preventing cognitive decline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Facilitators for participation and adherence
The multidomain intervention will be pilot tested in 2 wards, one rural and one urban.
Measured: Baseline and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Apr 2024
- Primary completion31 Jan 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Believers Church Medical College Hospital, Tiruvalla, Kerala, India
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD,, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488430
- Sponsor's protocol ID
- STUDY23010015
- Other IDs
- 5D43TW009114-10
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment Among Community Dwelling Adults: Prevalence, Associated Factors, and Feasibility of a Multidomain Intervention Package for Preventing Cognitive Decline
- ClinicalTrials.gov ID
- NCT06488430
- Acronym / sponsor ID
- STUDY23010015
- Conditions
- Mild Cognitive Impairment
- Keywords
- Dementia, cognitive ability, Mild cognitive impairment (MCI), Multidomain intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Believers Church Medical College Hospital, Tiruvalla, Kerala, India
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To estimate the burden of mild cognitive impairment among community dwelling adults between 50-65 years in a taluk of a South Kerala district
- To develop a multidomain intervention package for preventing cognitive decline in those with mild cognitive impairment
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group for Multidomain intervention package for preventing cognitive decline | – | Behavioral: Multidomain intervention package for preventing cognitive declineA multidomain intervention including nutritional advice, physical activity, cognitive stimulation training, social support and engagement and management of vascular risk factors. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain intervention package for preventing cognitive declineParticipants 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. | Behavioural | Intervention Group for Multidomain intervention package for preventing cognitive decline |
Primary outcome
Prevalence and types of mild cognitive impairment
Time frame: Six months
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
Facilitators for participation and adherence
Time frame: Baseline and after intervention
The multidomain intervention will be pilot tested in 2 wards, one rural and one urban.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishwajit L Nimgaonkar, MD, principal investigator
university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by University of Pittsburgh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and types of mild cognitive impairment (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.