DiabetesNCT07250789
Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
A study testing Multidomain Intervention Targeting Cognitive Decline in people with Diabetes and Diabetes Mellitus Type 2, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus Type 2, Type 2 Diabetes
- What is being tested?
- Multidomain Intervention Targeting Cognitive Decline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jun 2024to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Endocrinology, Rigshospitalet
Copenhagen, 2100
Malin S. D. Nilsson, MD, PhD, +45 50 59 58 61, malin.nilsson@regionh.dk
Thomas Almdal, Professor, MD, DMSc
- Recruiting
Department of Endocrinology, Bispebjerg-Frederiksberg Hospital
Copenhagen, 2400
Malin S. D. Nilsson, MD, PhD, + 45 50 59 58 61, malin.nilsson@regionh.dk
Mette Zander, Associate professor, MD PhD
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Malin S. D. Nilsson, MD, PhD, +45 50 59 58 61, malin.nilsson@regionh.dk
Malin S. D. Nilsson, MD, PhD
About this study
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)
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.
Read the 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.
- Conditions
- Diabetes, Diabetes Mellitus Type 2, Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Cognitive Impairment, Cognitive Decline
- Being tested
- Multidomain Intervention Targeting Cognitive Decline
- Keywords
- diabetes, type 2 diabetes, type 2 diabetes mellitus, t2d, t2dm, cognitive impairment, cognitive decline
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain Intervention Targeting Cognitive DeclineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Multidomain Intervention Targeting Cognitive Decline |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Cognitive Function
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.
Measured: 2 years
Secondary outcomes (2)
The Number of Hospitalizations Related to All-cause Disease
Measured: 2 years
Changes in Health-related Quality of Life Measured by SF-36
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jun 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jørgen Rungby, Professor, MD, DMSc, Study chair, Steno Diabetes Center CopenhagenMalin S.D. Nilsson, MD, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250789
- Sponsor's protocol ID
- H-24006680
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07250789
- Acronym / sponsor ID
- H-24006680
- Conditions
- Diabetes, Diabetes Mellitus Type 2, Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Cognitive Impairment, Cognitive Decline
- Keywords
- diabetes, type 2 diabetes, type 2 diabetes mellitus, t2d, t2dm, cognitive impairment, cognitive decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multidomain Intervention Targeting Cognitive Decline |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain Intervention Targeting Cognitive DeclineThe 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. | Other | Intervention |
Primary outcome
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jørgen Rungby, Professor, MD, DMSc study chair
Steno Diabetes Center Copenhagen
Malin S.D. Nilsson, MD, PhD principal investigator
Steno Diabetes Center Copenhagen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain Intervention Targeting Cognitive Decline in people with Diabetes and Diabetes Mellitus Type 2, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin S. D. Nilsson, MD, PhD (+4550595861, malin.nilsson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Change in Cognitive Function (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.