Cognitive Decline, Cognitive Impairment, Diabetes, Diabetes Mellitus Type 2, Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
diabetes, type 2 diabetes, type 2 diabetes mellitus, t2d, t2dm, cognitive impairment, cognitive decline
Brief summary
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.
Detailed description
Type 2 diabetes (T2D) is a chronic condition associated with cognitive decline and an increased risk of Alzheimer's disease and vascular dementia. Cognitive impairment in individuals with T2D complicates disease management, often leading to poorer clinical outcomes. Although guidelines recommend cognitive screening for older adults with T2D, uncertainties remain regarding how to best identify high-risk individuals and adjust treatment strategies. While multidomain interventions have shown potential in delaying cognitive decline, further research is needed to develop feasible and effective strategies for at-risk populations. The Brain Care Study consists of two parts: a prevalence study involving cognitive screening and a two-year randomized controlled trial (RCT) to assess a multidomain intervention targeting multiple risk factors, including pharmacological optimization, lifestyle changes, and social interaction. The multidomain intervention focuses on optimizing medication, adjusting HbA1c targets, managing vascular risk factors, and addressing hearing impairment, depression, physical activity, and cognitive training. Additionally, the study will employ dialogue tools, text message reminders, and social interaction to enhance participants' health and adherence to the intervention. The study hypothesizes that cognitive screening will be feasible and will not increase diabetes-related distress, while the intervention may reduce cognitive decline, improve health-related quality of life, decrease hospitalization rates, and minimize the need for home visits or relocation to nursing homes. Study endpoints include the prevalence of cognitive impairment, changes in cognitive function, hospitalization rates, and medication adherence, with the goal of providing evidence-based recommendations for future diabetes care guidelines. Overall, the Brain Care Study aims to quantify the prevalence of cognitive decline in older individuals with type 2 diabetes and generate data to inform future guidelines for cognitive screening and interventions in this population.
Interventions
OTHERMultidomain Intervention Targeting Cognitive Decline
The multidomain intervention will include the following: Optimization of pharmacological treatment/Pharmacological neuroprotection. Adjustment of HbA1c targets. Vascular risk factor management. Assessment of hearing impairment. Assessment of depression. Dialogue tools. Social interaction. Guidance on physical training. Cognitive training. Text message reminders.
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Change in Cognitive Function | 2 years | Difference in change in cognitive function (visit 1 compared to follow-up) measured by SCIP between the multifactorial intervention group and the usual care group. |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Hospitalizations Related to All-cause Disease | 2 years |
| Changes in Health-related Quality of Life Measured by SF-36 | 2 years |
Countries
Denmark
Contacts
Primary ContactMalin S. D. Nilsson, MD, PhD
Outcome results
None listed