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Loneliness as Risk Factor for Dementia (SOLETE)

C

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Begins enrollment this month

Conditions

Mild Cognitive Impairment (MCI)
Loneliness
Dementia (Diagnosis)

Study type

Observational

Funder types

Other

Identifiers

NCT07211945
CSAPG-80

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.

Trial design

300 participants in 2 patient groups

Loneliness positive
Description:
Patients with mild cognitive impairment (MCI) and loneliness
Loneliness negative
Description:
Patients with mild cognitive impairment (MCI) without loneliness

Trial contacts and locations

1

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Central trial contact

Noemí Casaponsa

Data sourced from clinicaltrials.gov

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