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Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)
RECRUITINGN/ASponsored by Steno Diabetes Center Copenhagen
Actively Recruiting
PhaseN/A
SponsorSteno Diabetes Center Copenhagen
Started2024-06-01
Est. completion2029-06
Eligibility
Age65 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07250789
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
Age: 65 Years+Healthy volunteers accepted
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 excludedConditions6
Cognitive DeclineCognitive ImpairmentDiabetesDiabetes Mellitus, Type 2Type 2 DiabetesType 2 Diabetes Mellitus (T2DM)
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Actively Recruiting
PhaseN/A
SponsorSteno Diabetes Center Copenhagen
Started2024-06-01
Est. completion2029-06
Eligibility
Age65 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07250789