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Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)
Led by Steno Diabetes Center Copenhagen · Updated on 2025-11-26
420
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how common cognitive impairment is among older adults with type 2 diabetes and are evaluating a multidomain intervention aimed at preventing cognitive decline in this group. Type 2 diabetes is linked to worsening brain function and higher risks of Alzheimer's and vascular dementia, which complicates diabetes management. This study aims to improve understanding and care by screening for cognitive issues and testing new ways to slow decline. The study has two parts: first, a prevalence study with cognitive screening for older adults with type 2 diabetes, and second, a two-year randomized controlled trial comparing a multidomain intervention to usual care. The intervention includes optimizing medications, adjusting blood sugar targets, managing vascular risks, assessing hearing and depression, promoting physical and cognitive training, using dialogue tools, social interaction, and sending text reminders to support health and adherence. Participants will undergo cognitive tests and assessments, with researchers monitoring changes in cognitive function, hospitalizations, and quality of life over two years. The study will gather data on medication adherence and other health outcomes, aiming to offer evidence-based recommendations for future diabetes and cognitive care. The total participation includes screening and follow-up evaluations to track the intervention's impact and safety.
CONDITIONS
Brief Title
Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Diagnosis of Type 2 Diabetes (T2D)
- Patient at the outpatient clinic at Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen
- Speaks and understands Danish
- Provides informed written consent
- For the randomized trial, must meet above and have cognitive test results indicating increased risk of cognitive decline or dementia as specified by diabetes-specific dementia score or SCIP/MoCA test scores
You will not qualify if you...
- Diagnosis of dementia or prior referral to a dementia clinic
- Diagnosis of psychiatric, neurological, or other disorders that hinder participation or affect study compliance
- For the randomized trial, those with dementia indicated by cognitive screening or unwilling to engage in parts of the intervention are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants receive a multidomain intervention including medication optimization, adjustment of HbA1c targets, vascular risk factor management, assessments for hearing impairment and depression, guidance on physical and cognitive training, social interaction, and supportive text message reminders.
Regular visits as per intervention schedule
Duration - 2 years
Participants receiving routine diabetes care without the multidomain intervention are observed for comparison of outcomes.
Visit frequency aligned with routine care
Trial Site Locations
Total: 3 locations
1
Department of Endocrinology, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
Department of Endocrinology, Bispebjerg-Frederiksberg Hospital
Copenhagen, Denmark, 2400
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3
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
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Research Team
M
Malin S. D. Nilsson, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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