Cognitive screening and multidomain care to slow memory and thinking decline in older adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project has two parts: a prevalence phase offering cognitive screening to older adults with type 2 diabetes, and a two-year randomized trial of a multidomain intervention for those at elevated risk. The intervention combines medication optimization, individualized HbA1c targets, management of vascular risks, hearing and mood care, increased physical activity and cognitive training, plus dialogue tools, text reminders, and social interaction supports. Participants are recruited from three Copenhagen-area endocrinology clinics and must be 65 or older, have T2D, speak Danish, and provide informed consent. Primary goals are to test the feasibility and acceptability of screening and to see if the intervention reduces cognitive decline compared with usual care.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Endocrinology, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Endocrinology, Bispebjerg-Frederiksberg Hospital
  Copenhagen, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting

Study contacts

• Principal investigator: Malin S.D. Nilsson, MD, PhD — Steno Diabetes Center Copenhagen
• Study coordinator: Malin S. D. Nilsson, MD, PhD
• Email: malin.nilsson@regionh.dk
• Phone: +4550595861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.