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

Sponsor

Jose Seijas Amigo (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04319081

Collaborator

(none)

180

Enrollment

Locations

35.1

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function Hypercholesterolemia Quality of Life	Drug: PCSK9 inhibitor

Study Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Uncontrolled patients with hypercholesterolemia

Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab

Drug: PCSK9 inhibitor

Patients are included after PCSK9 inhibitors prescription , at the first dispensation

Outcome Measures

Primary Outcome Measures

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

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/
Direct costs [24 to 36 months]
Direct costs related with treatments and consultations (€)

Other Outcome Measures

Total Cholesterol [24 to 36 months]
Total cholesterol evolution during the study in mg/dL
Lp(a) [24 to 36 months]
Lp(a) evolution during the study in mg/dL
Cost-effectiveness [24 to 36 months]
€/QUALY

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Virxen da Xunqueira de Cee	Cee	A Coruña	Spain
2	Hospital Arquiteto Marcide de Ferrol	Ferrol	A Coruña	Spain
3	Hospital del Barbanza	Ribeira	A Coruña	Spain
4	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña	Spain
5	Hospital Público da Mariña de Burela	Burela	Lugo	Spain
6	Hospital de Monforte	Monforte De Lemos	Lugo	Spain
7	Hospital do Barco de Valdeorras	O Barco De Valdeorras	Ourense	Spain
8	Hospital Alvaro Cunqueiro de Vigo	Vigo	Pontevedra	Spain
9	Complejo Hospitalario Universitario de A Coruña	A Coruña		Spain	15706
10	Hospital Lucus-Augusti de Lugo	Lugo		Spain
11	Complejo Hospitalario Universitario de Ourense	Ourense		Spain
12	Complexo Hospitalario Universitario de Pontevedra	Pontevedra		Spain