NCT07250789

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
37mo left

Started Jun 2024

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jun 2024Jun 2029

Study Start

First participant enrolled

June 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

DiabetesDiabetes Mellitus Type 2Type 2 DiabetesType 2 Diabetes Mellitus (T2DM)Cognitive ImpairmentCognitive Decline

Keywords

diabetestype 2 diabetestype 2 diabetes mellitust2dt2dmcognitive impairmentcognitive decline

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (2)

  • The Number of Hospitalizations Related to All-cause Disease

    2 years

  • Changes in Health-related Quality of Life Measured by SF-36

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Multidomain Intervention Targeting Cognitive Decline

Usual Care

NO INTERVENTION

Interventions

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Endocrinology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Endocrinology, Bispebjerg-Frederiksberg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jørgen Rungby, Professor, MD, DMSc

    Steno Diabetes Center Copenhagen

    STUDY CHAIR

  • Malin S.D. Nilsson, MD, PhD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin S. D. Nilsson, MD, PhD

CONTACT

+4550595861malin.nilsson@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

DK(3)