Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
NCT ID: NCT07250789
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2024-06-01
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
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.
Usual Care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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
* 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
* 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
65 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Principal Investigators
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Jørgen Rungby, Professor, MD, DMSc
Role: STUDY_CHAIR
Steno Diabetes Center Copenhagen
Malin S.D. Nilsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Department of Endocrinology, Rigshospitalet
Copenhagen, , Denmark
Department of Endocrinology, Bispebjerg-Frederiksberg Hospital
Copenhagen, , Denmark
Steno Diabetes Center Copenhagen
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-24006680
Identifier Type: -
Identifier Source: org_study_id
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