Clinical trial: Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease (NCT03578991)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Contradiction