Cognitive screening and multidomain care to slow memory and thinking decline in older adults with type 2 diabetes
Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)
This study will test whether regular cognitive screening plus a two-year program of medication optimization, adjusted HbA1c targets, vascular risk management, lifestyle changes, and social support can slow cognitive decline in people aged 65 and older with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT07250789 on ClinicalTrials.gov |
What this trial studies
The project has two parts: a prevalence phase offering cognitive screening to older adults with type 2 diabetes, and a two-year randomized trial of a multidomain intervention for those at elevated risk. The intervention combines medication optimization, individualized HbA1c targets, management of vascular risks, hearing and mood care, increased physical activity and cognitive training, plus dialogue tools, text reminders, and social interaction supports. Participants are recruited from three Copenhagen-area endocrinology clinics and must be 65 or older, have T2D, speak Danish, and provide informed consent. Primary goals are to test the feasibility and acceptability of screening and to see if the intervention reduces cognitive decline compared with usual care.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking people aged 65 or older with type 2 diabetes who receive care at one of the participating Copenhagen clinics and show mild cognitive impairment or an elevated diabetes-specific dementia risk score.
Not a fit: People with an established dementia diagnosis, those younger than 65, non-Danish speakers, or individuals without measurable cognitive impairment are unlikely to benefit from this specific trial intervention.
Why it matters
Potential benefit: If successful, the approach could slow cognitive decline and improve diabetes self-management and daily functioning for older adults with type 2 diabetes.
How similar studies have performed: Previous multidomain intervention trials have shown some promise in delaying cognitive decline, but this approach has not been definitively proven specifically in older adults with type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the Prevalence Study (Cognitive Screening):
* 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
Inclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention):
* Meets all the above inclusion criteria, and at least one of the following:
1. 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
2. A SCIP or MoCA score ≥ 1 SD below the age- and education-adjusted norm
3. At least 2 out of 5 SCIP subtests with a score ≥ 1 SD below the age- and education-adjusted norm
Exclusion Criteria for the Prevalence Study (Cognitive Screening):
* Diagnosis of dementia or prior referral to a dementia clinic
* 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
Exclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention):
* Meets all the above exclusion criteria
* Participants whose cognitive MoCA screening indicates dementia will be excluded and advised to contact their physician
* Participants unwilling to engage in parts of the multidomain intervention will be excluded
Where this trial is running
Copenhagen and 2 other locations
- Department of Endocrinology, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Department of Endocrinology, Bispebjerg-Frederiksberg Hospital — Copenhagen, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Malin S.D. Nilsson, MD, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Malin S. D. Nilsson, MD, PhD
- Email: malin.nilsson@regionh.dk
- Phone: +4550595861
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.