Diagnosed of Mild Cognitive Impairment Clinical Trial
Official title:
Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease: Comprehensive Approach and Adherence to Treatment: DIALCAT Project.
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).
The objective of the DIALCAT randomized controlled trial is to study the effects of an
eHealth intervention (smart pillbox, digital platform) on the progression of cognitive
impairment evaluated by means of a neuropsychological examination, in a sample of elderly
patients with type II diabetes (T2D) and mild cognitive impairment (MCI). As secondary goals,
this research is intended to:
1. Assess if the intervention improves the metabolic control of the study sample.
2. Evaluate the effects of the intervention on the conversion rate (yes vs. no) from MCI to
Alzheimer's' disease (AD).
3. Compare the effectiveness of the interventions to reduce functional decline (quantified
by a battery of neuropsychological tests [see detailed description below]) and the
conversion rate to AD.
4. Identify the clinical and analytical predictors (biomarkers) of conversion from MCI to
AD.
To this purposes, a total of 174 T2D patients with MCI (MMSE≥24) will be recruited with a
18-month follow-up. Eligible patients will be randomized in a 1:1:1 ratio in one of the arms
of the RCT (for randomization, a sex-by-sex-swapped sequence and the ApoE genotype will be
used). The three groups will receive the following interventions:
Arm 1: T2D patients (n = 58) with MCI, receiving treatment as usual (TAU) by their primary
care physician/endocrinologist.
Arm 2: T2D patients (n = 58) with MCI, receiving TAU and using a smart pillbox that allows to
monitor adherence to treatment.
Arm 3: T2D patients (n = 58) with MCI, receiving TAU, using the smart pillbox and receiving
periodic feedback on their metabolic control and how to improve it by an endocrinologist via
a digital platform.
Since it is expected that the different factors related to the intervention will have an
additive or synergistic effect, the hypothesis is that the cognitive impairment and
progression of MCI to AD would be higher in arm 1, followed by arm 2 and, finally, arm 3.
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