Status:

NOT_YET_RECRUITING

Loneliness as Risk Factor for Dementia

Lead Sponsor:

Consorci Sanitari de l'Alt Penedès i Garraf

Conditions:

Mild Cognitive Impairment (MCI)

Dementia (Diagnosis)

Eligibility:

All Genders

70+ years

Brief Summary

This study aims to determine whether loneliness is associated with a higher incidence of dementia in older adults with a prior diagnosis of mild cognitive impairment after 12 months of follow-up.

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2026

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2028

    Estimated Enrollment :

    300 Patients enrolled

    Trial Details

    Trial ID

    NCT07211945

    Start Date

    March 1 2026

    End Date

    September 1 2028

    Last Update

    November 26 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Hospital Sant Antoni Abat

    Vilanova i la Geltrú, Barcelona, Spain