Loneliness as Risk Factor for Dementia

NCT07211945 | Not Yet Recruiting

• 1 other identifier: CSAPG-80
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cognitive Dysfunction; Dementia; Loneliness

Outcome Measures

Primary Outcomes (1)

• Dementia

  Number of patients who show clinical progress from MCI to dementia

  12 months

Study Arms (2)

Loneliness positive

Patients with mild cognitive impairment (MCI) and loneliness

Loneliness negative

Patients with mild cognitive impairment (MCI) without loneliness

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older people affected by mild cognitive impairment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Hospital Sant Antoni Abat

Vilanova i la Geltrú, Barcelona, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Noemí Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)