Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)

November 18, 2025 updated by: Steno Diabetes Center Copenhagen

Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Endocrinology, Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Thomas Almdal, Professor, MD, DMSc
      • Copenhagen, Denmark, 2400
        • Recruiting
        • Department of Endocrinology, Bispebjerg-Frederiksberg Hospital
        • Contact:
        • Principal Investigator:
          • Mette Zander, Associate professor, MD PhD
      • Herlev, Denmark, 2730
        • Recruiting
        • Steno Diabetes Center Copenhagen
        • Contact:
        • Principal Investigator:
          • Malin S. D. Nilsson, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
No Intervention: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Change in Cognitive Function
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The Number of Hospitalizations Related to All-cause Disease
Time Frame: 2 years
2 years
Changes in Health-related Quality of Life Measured by SF-36
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Investigators

  • Study Chair: Jørgen Rungby, Professor, MD, DMSc, Steno Diabetes Center Copenhagen
  • Principal Investigator: Malin S.D. Nilsson, MD, PhD, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24006680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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