An observational study in Mild Cognitive Impairment (MCI), Dementia (Diagnosis) and Loneliness, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Not yet recruiting at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Observational
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 36 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Older people affected by mild cognitive impairment
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.
Patients with mild cognitive impairment (MCI) and loneliness
Patients with mild cognitive impairment (MCI) without loneliness
Dementia
Number of patients who show clinical progress from MCI to dementia
Time frame: 12 months
Plan to share: Yes — IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari de l'Alt Penedès i Garraf