Clinical trial Recruiting at 1 site Observational Ages 70 and up

Loneliness linked to dementia risk in older adults with mild cognitive impairment

Official title: Loneliness as a Risk Factor for Dementia in Patients With Mild Cognitive Impairment: A Prospective Study

Run by Consorci Sanitari de l'Alt Penedès i Garraf · NCT07211945 · Data updated 2026-11-12

This study will look to see if loneliness is associated with a higher chance of developing dementia within 12 months in people aged 70 and older who have mild cognitive impairment.

More Loneliness trials

Quick facts

Study typeObservational
Ages70 Years and up
SexAll
Enrollment300 (estimated)
SponsorConsorci Sanitari de l'Alt Penedès i Garraf
Academic / other
Locations1 site (Vilanova i la Geltrú, Barcelona)
StatusRecruiting
StartedOctober 8, 2026
Main results expectedSeptember 2028
Study endsSeptember 2028
Registry record updatedOctober 28, 2026
Trial IDNCT07211945 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 70 and older with a recent diagnosis of mild cognitive impairment per Petersen's criteria, able to consent or have a legal representative consent, and able to complete required assessments at UMAG.

Probably not a fit

Individuals with established dementia at enrollment or who cannot complete follow-up assessments may not benefit from findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows older adults with mild cognitive impairment to see whether feelings of loneliness correlate with the onset of dementia over a year. Participants are seen at the Alzheimer's Disease and Other Dementias Unit of Garraf (UMAG) and will undergo assessments as part of routine follow-up. The study uses real-world clinical data and standardized criteria to help clarify whether loneliness is a risk marker for progression to dementia. No active experimental treatment is being tested. Results could inform future strategies for identifying individuals at higher risk and guiding supportive interventions.

Why it matters

Potential benefit: If loneliness is linked to dementia risk, better screening and targeted social or supportive measures could be developed to help at-risk individuals.

How similar studies have gone: Previous observational research has shown associations between loneliness and cognitive outcomes, but results vary and this study adds context within a Spanish clinical setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hospital Sant Antoni Abat
    Vilanova i la Geltrú, Barcelona, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.