Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
Recruiting · NCT07250789 · Interventional (participants receive a specific treatment) · Lead sponsor: Steno Diabetes Center Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
Multidomain Intervention Targeting Cognitive Decline
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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:
- 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
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 it is running
3 locations listed.
- Department of Endocrinology, Rigshospitalet - Copenhagen, Denmark
- Department of Endocrinology, Bispebjerg-Frederiksberg Hospital - Copenhagen, Denmark
- Steno Diabetes Center Copenhagen - Herlev, Denmark