RecruitingNot ApplicableNCT07250789

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

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

Sponsor

Steno Diabetes Center Copenhagen

Enrollment

420 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment Diabetes Mellitus, Type 2 Cognitive Decline Diabetes Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria8

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

Exclusion Criteria4

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

Interventions

OTHERMultidomain 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.