Multicenter, Observational and Prospective Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors (MEMOGAL)
Overview
- Phase
- N/A
- Intervention
- PCSK9 inhibitor
- Conditions
- Cognitive Function
- Sponsor
- Jose Seijas Amigo
- Enrollment
- 180
- Locations
- 12
- Primary Endpoint
- Changes in cognitive function
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Jose Seijas Amigo
Pharmacist
Hospital Clinico Universitario de Santiago
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
Arms & Interventions
Uncontrolled patients with hypercholesterolemia
Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab
Intervention: PCSK9 inhibitor
Outcomes
Primary Outcomes
Changes in cognitive function
Time Frame: 24 to 36 months
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.
Secondary Outcomes
- Direct costs(24 to 36 months)
- LDL-cholesterol values(24 to 36 months)
- Changes in Quality of life(24 to 36 months)