NCT03578991: DIALCAT

Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease

Completed NA Last updated 14 August 2020

What this trial tests

NA trial testing Smart pillbox in Patients Aged 65-85 (Both Included) in 54 participants. Completed in 15 April 2020.

Timeline

1 July 2019

Primary endpoint
15 April 2020

15 April 2020

Quick facts

Lead sponsor	Parc Sanitari Pere Virgili
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	54
Start date	1 July 2019
Primary completion	15 April 2020
Estimated completion	15 April 2020
Sites	8 locations across Spain

Drugs / interventions tested

• Smart pillbox
• Interactive digital platform

Conditions studied

• Patients Aged 65-85 (Both Included) — all drugs for Patients Aged 65-85 (Both Included) →
• Diagnosed of Mild Cognitive Impairment — all drugs for Diagnosed of Mild Cognitive Impairment →
• Diagnosed of Type 2 Diabetes in Active Treatment (Hypoglycemic Agents) for a Period ≥5 Years — all drugs for Diagnosed of Type 2 Diabetes in Active Treatment (Hypoglycemic Agents) for a Period ≥5 Years →

Sponsor

Parc Sanitari Pere Virgili — full company profile →

Who can join

Adults 65 to 85, any sex, with Patients Aged 65-85 (Both Included) or Diagnosed of Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized controlled trial is aimed at studying the effects of an eHealth intervention on improving metabolic control and other cardiovascular risk factors (obesity, lipidic profile and hypertension) as the approach to prevent or delay the process of cognitive impairment, and to reduce conversion rates to Alzheimer's disease (AD) in a sample of patients diagnosed of type 2 diabetes mellitus (T2D) and with mild cognitive impairment (MCI).

For these purposes, the standard clinical treatment for this type of patients will be compared with two types of interventions (parallel groups): one aimed at promoting adherence to treatment through the use of a smart pillbox; and the other intervention will be based on the use of the smart pillbox plus and interactive digital platform allowing communication between patients and caregivers with healthcare professionals. Both interventions are targeted to improve adherence to treatment.

The hypothesis is that the rate of conversion from MCI to AD will be higher in the control group than in the intervention groups (higher conversion rates are expected in control group, followed by the smart pillbox group, and lower conversion rates are expected in the group using the interactive digital platform and the smart pillbox).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neurodegeneration in type 2 diabetes: Alzheimer's as a case study.
   Madhusudhanan J, Suresh G, Devanathan V. · · 2020 · cited 45× · PMID 32170854 · DOI 10.1002/brb3.1577
2. Cognitive Profile and Cardiovascular Risk Factors in Older Adults with Mild Cognitive Impairment.
   Vázquez-de Sebastián J, Ortiz-Zuñiga AM, Ciudin A, Ars J, et al · · 2024 · cited 2× · PMID 38673411 · DOI 10.3390/ijerph21040500