NCT07250789Recruiting
Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
The purpose of The Brain Care Study is to investigate the prevalence of cognitive impairment in older adults with type 2 diabetes (T2D) and to evaluate the effectiveness of a multidomain intervention designed to prevent cognitive decline.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 1 Jun 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 2 diabetes
- NCT number
- NCT07250789
What you commit to
- Study type: Interventional
- Planned participants: 420
- From 1 Jun 2024 to the primary completion date, Jun 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of dementia or prior referral to a dementia clinic
Other illness
- Diagnosis of psychiatric, neurological, or other disorders that, in the investigator's opinion, hinder participation in cognitive screening, preclude compliance with the study protocol, or affect the evaluation of results
- Participants whose cognitive MoCA screening indicates dementia will be excluded and advised to contact their physician
Other
- Meets all the above exclusion criteria
- Participants unwilling to engage in parts of the multidomain intervention will be excluded
Who the study is looking for
- Age ≥ 65 years
- Diagnosis of Type 2 Diabetes (T2D)
- Patient at the outpatient clinic at either Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen
- Speaks and understands Danish (required for the cognitive tests)
- Informed written consent
- Meets all the above inclusion criteria, and at least one of the following:
- A diabetes-specific dementia score ≥ 7 (equivalent to a 40% increased risk of developing dementia within the next 10 years), and a SCIP or MoCA score ≥ 0.5 SD below the age- and education-adjusted norm
- A SCIP or MoCA score ≥ 1 SD below the age- and education-adjusted norm
- At least 2 out of 5 SCIP subtests with a score ≥ 1 SD below the age- and education-adjusted norm
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, Bispebjerg-Frederiksberg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Department of Endocrinology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.