No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
420 (estimated)
Sponsor
Steno Diabetes Center Copenhagen · Other
Who this trial is looking for
This trial is looking for older adults with type 2 diabetes who want to help understand and improve brain health. Participants will undergo cognitive tests and may receive interventions aimed at preventing cognitive decline.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 65 years old
I have been diagnosed with type 2 diabetes
I visit an outpatient clinic at Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen
I speak and understand Danish
I can provide informed written consent
You may not be able to join if
I have been diagnosed with dementia
I have been referred to a dementia clinic
I have a psychiatric or neurological disorder that affects my participation
I am unwilling to engage in parts of the intervention
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Status
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 …
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
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