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

Completed

• Conditions: Cognitive Function; Hypercholesterolemia; Quality of Life
• Interventions: Drug: PCSK9 inhibitor

• Registration Number: NCT04319081
• Lead Sponsor: Jose Seijas Amigo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-13
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uncontrolled patients with hypercholesterolemia	PCSK9 inhibitor	Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab

Primary Outcome Measures

Name	Time	Method
Changes in cognitive function	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 Outcome Measures

Name	Time	Method
Direct costs	24 to 36 months	Direct costs related with treatments and consultations (€)
LDL-cholesterol values	24 to 36 months	LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)
Changes in Quality of life	24 to 36 months	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/

Trial Locations

Locations (12)

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Complexo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital do Barco de Valdeorras; 🇪🇸 O Barco De Valdeorras, Ourense, Spain

Hospital del Barbanza; 🇪🇸 Ribeira, A Coruña, Spain

Hospital de Virxen da Xunqueira de Cee; 🇪🇸 Cee, A Coruña, Spain

Hospital Arquiteto Marcide de Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Público da Mariña de Burela; 🇪🇸 Burela, Lugo, Spain

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Complejo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Hospital Lucus-Augusti de Lugo; 🇪🇸 Lugo, Spain

Hospital de Monforte; 🇪🇸 Monforte De Lemos, Lugo, Spain

Hospital Alvaro Cunqueiro de Vigo; 🇪🇸 Vigo, Pontevedra, Spain