Diagnosed of Mild Cognitive Impairment Clinical Trial
— DIALCATOfficial title:
Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease: Comprehensive Approach and Adherence to Treatment: DIALCAT Project.
| Verified date | August 2020 |
| Source | Parc Sanitari Pere Virgili |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | April 15, 2020 |
| Est. primary completion date | April 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 85 Years |
| Eligibility |
Inclusion criteria: 1. Patients diagnosed of diabetes mellitus type 2 with time evolution ?5 years. 2. Age between 65 and 85 years old (both included). 3. Ability to read and write. 4. Active treatment with hypoglycemic agents. 5. Diagnosed with mild cognitive impairment. Exclusion Criteria: 1. Familiar history of Alzheimer's' disease. 2. Patients with any type of dementia. 3. History of neurological or psychiatric conditions not stabilized that can substantially affect cognition. 4. 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/m2. - Decompensated cirrhosis or liver failure. - Untreated hypothyroidism or vitamin B12 deficiency. If known. - Active cancer or chemotherapy treatment the previous year. 5. Treatment with drugs that alter the cognitive state, for example: - Antipsychotic. - Daily consumption of opioids. - Benzodiazepines (BZD) long action (for example Diazepam). Benzodiazepines (BZD) short-acting at high doses such as Alprazolam at doses greater than 1 mg / day; Lorazepam at doses greater than 1 mg / day and Lormetazepam at doses greater than 1 mg / day. - Fentanil patches in doses greater than 2.5 mg every 72 h. - Gabapentin in doses greater than 600 mg / day. - Pregabalin in doses greater than 50 mg / day. - Amitriptyline in doses greater than 25 mg / day. 6. Limitations of mobility that can avoid or restrict the application or evaluation of the intervention. 7. Patients with other types of diabetes: diabetic mellitus type 1, LADA; MODY 8. Unstable advanced diabetic retinopathy 9. Patients with serious uncorrected sensory deficits that make assessment impossible (blindness, deafness). 10. Patients with access to other online platforms for patients. 11. Patients with access to other intelligent electronic dispensing devices for improved adherence to treatment. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | LambdaLoopers | Barcelona | |
| Spain | Parc Sanitari Pere Virgili | Barcelona | |
| Spain | University Hospital Vall d'Hebron - Vall d'Hebron Institute of Research | Barcelona | |
| Spain | Fundació Privada Hospital Asil de Granollers (HAG) | Granollers | Barcelona |
| Spain | Fundació Althaia (FA) | Manresa | Barcelona |
| Spain | Consorci Sanitari de Terrassa (CST) | Terrassa | Barcelona |
| Spain | Fundació Recerca Mútua Terrassa (FMT) | Terrassa | Barcelona |
| Spain | Consorci Hospitalari de Vic (CHV) | Vic | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Parc Sanitari Pere Virgili | Althaia Xarxa Assistencial Universitària de Manresa, Clínica Universitària de la Fundació Universitària del Bages (FUB), Consorci Hospitalari de Vic, Consorci Sanitari de Terrassa, Fundació Privada Hospital Asil de Granollers (HAG), Fundació Recerca Mútua Terrassa (FMT), Hospital Vall d'Hebron, LambdaLoopers, Leitat, Meditecnologia, Mixestat, Universitat Politècnica de Catalunya |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of score obtained in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | 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. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Cardiovascular risk factor: Hypertension. | Hypertension (mmHg) will be registered. Both pressures will be assessed (systolic and diastolic). This information will be extracted from clinical records. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Cardiovascular risk factor: Obesity. | Body Mass Index (BMI) will be calculated. Weight and height will be combined to calculate and report BMI. This information will be extracted from clinical records. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Cardiovascular risk factor: Dyslipidemia. | Dyslipidemia (md/dL) will be screened. This information will be extracted from clinical records. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Degree of diabetes control. | For the degree of diabetes control will be registered from blood tests level of glycosylated hemoglobin, plasma glucose and insulinemia in fasting. | At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment. | |
| Secondary | Usal medication. | Medication for hypertension, dyslipidemia and diabetes will be extracted from clinical records. Type of treatment, dosage, route of administration, frequency and changes in medication will be registered and listed. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Presence of micro and macrovascular complications. | The presence and severity of retinopathy, nephropathy (microalbuminuria levels), polyneuropathy and/or cardiovascular disease (specifically, ischemic heart disease, cerebrovascular accident or peripheral arterial disease) will be extracted from medical records. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Presence and severity of hypoglycemia. | Patients will be asked about the presence and severity of hypoglycaemia by answering a self-reported measure developed ad hoc by the Endocrinology Service of the Vall d'Hebron University Hospital. Patients with ambulatory insulinization will have a glucometer which will be reviewed by the doctor at each visit. Wil considerate hypoglycemia when the capillary glucose levels are between 70-50 mg/dl, and hypoglycemia when the levels are <50 mg/dl. All hypoglycemia will be registered. | At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | Lipid profile and renal and hepatic function. | Levels of low-density lipoprotein cholesterol (mg/dl), high-density lipoprotein cholesterol (mg/dl), triglycerides (mg/dl), creatinine (mg/dl), glomerular filtration (ml/min/m2), aspartate aminotransferase (U/L) and alanine aminotransferase (U/L) will be registered by means of blood tests. A final composite (bad vs. good lipidic profile and hepatic function) will be calculated based on these parameters. | At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment. | |
| Secondary | Biomarkers (serum and DNA). | Biomarkers (serum and DNA) will be registered by means of blood tests. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Short Physical Performance Battery test (SPPB). | The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Hachinski Scale (HS). | The HS allows differentiation of degenerative vascular dementias. A score =7 suggests vascular dementia and a score <4 points suggests Alzheimer's disease. The validity of this scale has been investigated in several clinical studies, considering a specificity and sensitivity of the order of 70-80%. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Blessed Dementia Rating Scale (BDRS). | The BDRS allows to screen for MCI and dementia in the elderly by quantifying performance in daily life activities by means of 28 items. The sensitivity according to the Cambridge Mental Disorders of the Elderly Examination (CAMCOG) was 90% with a specificity of 76%. A score >15 suggests moderate or severe dementia; a score between 4-14 suggests suspicion of dementia. | At baseline (at the moment of the study enrollment), at, 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | Geriatric Depression Scale (GDS; 15-item short form). | The Geriatric Depression Scale (GDS) is one of the most widely used instrument for the screening of depression in the elderly. This auto-administered questionnaire have shown to be sensitive to depression among elderly persons suffering from mild to moderate dementia and physical illness. The 15-item short version of the GDS (GDS-15) is considered useful in situations where economy of time is required. The score of the GDS-15 ranges from 0 to 15. A score of zero to four is considered to be within the normal range, five to nine indicates mild depression, and a score of 10 or more indicates moderate to severe depression. | At baseline (at the moment of the study enrollment), at, 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | Schwab and England Activities of Daily Living Scale (SE-ADL). | This scale describing the capacity for daily living shown by a patient with Parkinson's Disease and can be used for other conditions. This scale uses a percentage system to assign levels of independence and dependence, in which 100 percent represents complete independence and 0 percent complete dependence (bedridden). | At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | Montreal Cognitive Assessment (MOCA). | The MOCA is a cognitive screening test for MCI and Early Alzheimer's disease. According to the validation study, the sensitivity and specificity of the MOCA for detecting MCI were 90% and 87% respectively. Is a one-page 30-point test administered in approximately 10 minutes. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Mini-Mental State Examination (MMSE). | The MMSE is a brief cognitive test that assesses several cognitive domains, such as orientation, attention, concentration, memory, language, and constructional abilities. For the MMSE the sensitivity was 0.87 and 0.82 for specificity. | At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment. | |
| Secondary | Memory failure in everyday life questionnaire (MFE). | The MFE is one of the most widely-used instruments to assess memory failures in daily life to detect cognitive complaints. It consists of 28 items and has revealed a sensitivity of 83.1% with a specificity of 81.8% and positive predictor vale of 95.3%. | At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | The Functional Social Support Questionnaire (DUKE-UNC-11). | The DUKE-UNC-11 allows to measure the patient perception of the amount and type of personal social support. It was originally developed to measure social support in family medicine patients. Cut-off lower than 32 indicates low self-perceived social support. | At baseline (at the moment of the study enrollment), at 4, 9, 13 and an average of 18 months after enrollment. | |
| Secondary | The Resource Utilization in Dementia (RUD). | The RUD instrument is valid for assessing healthcare resource utilization among older adults with dementia and their caregivers, and time spent on formal and informal care by caregivers. | At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment. |