Mild Cognitive Impairment (MCI)SOLETENCT07211945
Loneliness as Risk Factor for Dementia
An observational study of Mild Cognitive Impairment (MCI) and Dementia (Diagnosis), run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia (Diagnosis), Loneliness
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older people affected by mild cognitive impairment
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Sant Antoni Abat
Vilanova i la Geltrú, Barcelona
Noemí Casaponsa, +34 938960025 ext. 43197, recerca@csapg.cat
Carlos Javier Fernández Noa
About this study
Official title: Loneliness as a Risk Factor for Dementia in Patients With Mild Cognitive Impairment: A Prospective Study
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.
- Keywords
- Cognitive Dysfunction, Dementia, Loneliness
- Medical subject headings
- Cognitive Dysfunction, Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Loneliness positive | Patients with mild cognitive impairment (MCI) and loneliness | |
| Loneliness negative | Patients with mild cognitive impairment (MCI) without loneliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia
Number of patients who show clinical progress from MCI to dementia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startMar 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211945
- Sponsor's protocol ID
- CSAPG-80
- Acronym
- SOLETE
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loneliness as a Risk Factor for Dementia in Patients With Mild Cognitive Impairment: A Prospective Study
- ClinicalTrials.gov ID
- NCT07211945
- Acronym / sponsor ID
- SOLETE / CSAPG-80
- Keywords
- Cognitive Dysfunction, Dementia, Loneliness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loneliness positive | – | –Patients with mild cognitive impairment (MCI) and loneliness |
| Loneliness negative | – | –Patients with mild cognitive impairment (MCI) without loneliness |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older people affected by mild cognitive impairment
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dementia
Time frame: 12 months
Number of patients who show clinical progress from MCI to dementia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Dementia (Diagnosis), run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemí Casaponsa (+34 938960025 ext. 43197, recerca@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.