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NCT Number: NCT07211945

Loneliness as Risk Factor for Dementia

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia (Diagnosis) Disease Loneliness Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Antoni Abat

Vilanova i la Geltrú, Barcelona, Spain

Location contact

Carlos Javier Fernández Noa

PRINCIPAL_INVESTIGATOR

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Dementia

    Time frame: 12 months

    Number of patients who show clinical progress from MCI to dementia

Study contacts

Contact information is provided by the study sponsor or research team.

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

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

Acronym: SOLETE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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