NCT07250789 Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
| NCT ID | NCT07250789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2024-06-01 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jørgen Rungby, Professor, MD, DMSc
STUDY CHAIR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT07250789 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07250789 currently recruiting?
Yes, NCT07250789 is actively recruiting participants. Contact the research team at malin.nilsson@regionh.dk for enrollment information.
Where is the NCT07250789 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Herlev, Denmark.
Who is sponsoring the NCT07250789 clinical trial?
NCT07250789 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Jørgen Rungby, Professor, MD, DMSc at Steno Diabetes Center Copenhagen. The trial plans to enroll 420 participants.
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