Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multidomain Intervention Targeting Cognitive Decline.
- Who it may be relevant to
- Registry conditions: Diabetes, Diabetes Mellitus Type 2, Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)
Overview
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
- Other Multidomain 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.
Primary outcome measures
- Difference in Change in Cognitive Function [Time frame: 2 years]
Secondary outcome measures (2)
- The Number of Hospitalizations Related to All-cause Disease [Time frame: 2 years]
- Changes in Health-related Quality of Life Measured by SF-36 [Time frame: 2 years]
Eligibility 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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 3 centers
- Department of Endocrinology, Rigshospitalet — Copenhagen
- Department of Endocrinology, Bispebjerg-Frederiksberg Hospital — Copenhagen
- Steno Diabetes Center Copenhagen — Herlev
Identifiers
NCT: NCT07250789 · H-24006680