Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors

Study Overview
=================
Brief Summary
-----------------
The main objective will be to evaluate the changes in the cognitive function in naive patients treated with PCSK9 inhibitors (Alirocumab and Evolocumab) by using the Montreal Cognitive Assesment questionnaire (MOCA). The secondary objectives will be: 1) To evaluate the levels of LDL-cholesterol changes from the beginning to the end of the study 2) To evaluate changes in Quality of Life among the EuroQol EQ-5D-3L questionnaire (it will also be associated to the cognitive function) 3) Assesment of direct costs in medications and outpatients consultations related with the health procedures.

Official Title
-----------------
Multicenter, Observational and Prospective Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors (MEMOGAL)

Conditions
-----------------
Cognitive Function, Hypercholesterolemia, Quality of Life

Intervention / Treatment
-----------------
* Drug: PCSK9 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old or over To start with the first funded dose of PCSK9 inhibitors ( LDL > 100 mg/dL) Maximum dose or statin intolerance Exclusion Criteria: Diagnosis of any disease related with cognitive deterioration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uncontrolled patients with hypercholesterolemia<br>Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab | Drug: PCSK9 inhibitor<br>* Patients are included after PCSK9 inhibitors prescription , at the first dispensation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognitive function | Assesment by Montreal Cognitive Assessment questionnaire (MOCA). Minimum value is 0 and maximum value is 30. A higher or equal value to 26 points will be considered normal. | 24 to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol values | LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL) | 24 to 36 months | 
| Changes in Quality of life | By using the questionnaire called EuroQol EQ-5D-3L assessment. It has 2 parts, the first one has 5 questions with 3 possible answers (5 dimensions and 3 levels), so each health status has a rate called EVA from 1,0000 (the highest value) to - 0,5095 (the worst health status). The second part is a visual self-assessment between 0 (the worst health status) and 100 (the best health status). https://euroqol.org/ | 24 to 36 months | 
| Direct costs | Direct costs related with treatments and consultations (€) | 24 to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Function, Hypercholesterolemia, Quality of Life, Pharmacoeconomics, PCSK9 inhibitors, Alirocumab, Evolocumab