Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease: Comprehensive Approach and Adherence to Treatment: DIALCAT Project.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients Aged 65-85 (Both Included)
- Sponsor
- Parc Sanitari Pere Virgili
- Enrollment
- 54
- Locations
- 8
- Primary Endpoint
- Change of score obtained in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Familiar history of Alzheimer's' disease.
- •Patients with any type of dementia.
- •History of neurological or psychiatric conditions not stabilized that can substantially affect cognition.
- •Severe metabolic or systemic disease that affects the cognitive state. This includes:
- •Unstable acute cardiovascular disease.
- •Renal failure with glomerular filtration rate \<30 ml/min/m
- •Decompensated cirrhosis or liver failure.
- •Untreated hypothyroidism or vitamin B12 deficiency. If known.
- •Active cancer or chemotherapy treatment the previous year.
- •Treatment with drugs that alter the cognitive state, for example:
Outcomes
Primary Outcomes
Change of score obtained in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Time Frame: At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.
The main variable of the study will be the score obtained in the RBANS in the different assessment periods. The RBANS was designed to be administered in adult population between 20 and 89 years. It is sensitive to the detection of cognitive disorder in degenerative and non-degenerative pathology. This battery evaluates 5 functions, by means of 12 subtests: 1) attention (repetition of digits and numerical key), 2) language (designation of drawings and semantic fluency), 3) visual-espacial / constructive ability (copy a figure and orientation of lines), 4) immediate memory (word learning and memory of the story) and 5) deferred memory (record of the list, word recognition, record of the story, record of the figure). The RBANS is a short battery (time of administration ≦30 minutes), and has two parallel forms of evaluation (forms A and B) to avoid the effect of learning.
Secondary Outcomes
- Cardiovascular risk factor: Obesity.(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Schwab and England Activities of Daily Living Scale (SE-ADL).(At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment.)
- Presence and severity of hypoglycemia.(At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment.)
- Hachinski Scale (HS).(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Montreal Cognitive Assessment (MOCA).(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- The Functional Social Support Questionnaire (DUKE-UNC-11).(At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment.)
- The Resource Utilization in Dementia (RUD).(At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment.)
- Cardiovascular risk factor: Dyslipidemia.(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Degree of diabetes control.(At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment.)
- Presence of micro and macrovascular complications.(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Lipid profile and renal and hepatic function.(At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment.)
- Blessed Dementia Rating Scale (BDRS).(At baseline (at the moment of the study enrollment), at, 4, 9, 13 and an average of 18 months after enrollment.)
- Usal medication.(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Mini-Mental State Examination (MMSE).(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Cardiovascular risk factor: Hypertension.(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Biomarkers (serum and DNA).(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Short Physical Performance Battery test (SPPB).(At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.)
- Memory failure in everyday life questionnaire (MFE).(At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment.)
- Geriatric Depression Scale (GDS; 15-item short form).(At baseline (at the moment of the study enrollment), at, 4, 9, 13 and an average of 18 months after enrollment.)