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Loneliness may raise dementia risk in seniors with mild cognitive impairment

NCT ID NCT07211945

Knowledge-focused Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study will follow 300 older adults (70+) who have mild cognitive impairment (MCI) for one year to see if feeling lonely makes them more likely to develop dementia. Researchers will track who progresses from MCI to dementia and compare loneliness levels. The goal is to understand whether social factors play a role in cognitive decline.

What this could mean

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

What this could lead to
If loneliness is confirmed as a risk factor, it could point toward social interventions to help prevent dementia in vulnerable older adults.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all populations.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

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

Older people affected by mild cognitive impairment

Ages

70 years and older

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 Patients may be included in the study if they meet all of the following criteria: Men and women aged 70 years or older. Diagnosis of mild cognitive impairment according to Petersen's criteria within the past 12 months. Follow-up of the condition under study at the Alzheimer's Disease and Other Dementias Unit of Garraf (UMAG) at the Consorci Sanitari Alt Penedès-Garraf (CSAPG). Expected follow-up of the condition at the study center. Ability to collaborate in the required assessments. Legal capacity to provide informed consent. Signed informed consent for inclusion in the study, either by the participant or their legal representative. Exclusion criteria Participants will be excluded from the trial if they meet any of the following criteria: Diagnosis of any of the following conditions: Dementia: the evaluating physician will rely on the diagnostic criteria of the Spanish Society of Neurology (SEN) and the results of the neuropsychological assessment performed at the UMAG. Participation in another study involving an experimental intervention during the present trial period and/or requiring a visit schedule incompatible with this trial.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction dementia disease

As listed by the trial registrant

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

Dementia (diagnosis) Loneliness Mild cognitive impairment (MCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Sant Antoni Abat

    Vilanova i la Geltrú, Barcelona, Spain

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