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Loneliness as Risk Factor for Dementia

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07211945
Acronym
SOLETE
Enrollment
300
Registered
2025-10-08
Start date
2026-03-31
Completion date
2028-09-30
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia (Diagnosis), Loneliness, Mild Cognitive Impairment (MCI)

Keywords

Cognitive Dysfunction, Dementia, Loneliness

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.

Interventions

None listed

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dementia12 monthsNumber of patients who show clinical progress from MCI to dementia

Countries

Spain

Contacts

Primary ContactNoemí Casaponsa
recerca@csapg.cat+34 938960025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026