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Lifestyle makeover may stave off dementia in At-Risk seniors

NCT ID NCT06488430

Prevention Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study looked at how common mild cognitive impairment is among adults aged 50-65 in Kerala, India, and tested a one-month program combining nutrition advice, exercise, brain games, social support, and heart health management. The goal was to see if this approach is practical and acceptable for preventing further cognitive decline. 481 participants were enrolled, and those with mild cognitive impairment received the intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
multidomain intervention package (nutritional advice, physical activity, cognitive stimulation training, social support, and management of vascular risk factors)
What this could lead to
If the intervention is found feasible, it could lead to larger clinical trials testing whether a combination of lifestyle changes can prevent or slow cognitive decline in older adults.
What could go wrong
This is a small, one-month feasibility study, not a large trial. The results may not apply to other populations, and the short duration cannot show long-term benefits or risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

20 people

The number who actually took part.

Started

Apr 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

50 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: • 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.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia Mild cognitive impairment

Contacts and locations

Locations

  • Believers Church Medical College

    Tiruvalla, Kerala, 689 103, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.