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

Conditions

Cognitive Function, Hypercholesterolemia, Quality of Life

Keywords

Cognitive Function, Hypercholesterolemia, Quality of Life, Pharmacoeconomics, PCSK9 inhibitors, Alirocumab, Evolocumab

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.

José Seijas‐Amigo, Maria José Mauriz-Montero, Pedro Suárez‐Artime, Mónica Gayoso‐Rey, Francisco Reyes-Santías et al. (21 authors)

Diseases2024-10-053 citations

10.3390/diseases12100244

Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World—MEMOGAL Study

José Seijas‐Amigo, Ma José Mauriz-Montero, Pedro Suárez‐Artime, Mónica Gayoso‐Rey, Ana Estany-Gestal et al. (38 authors)

American Journal of Cardiovascular Drugs2023-08-2310 citations

10.1007/s40256-023-00604-6

Impact of the COVID-19 pandemic in the lipid control of the patients that start PCSK9 inhibitors.

Seijas-Amigo J, Gayoso-Rey M, Mauriz-Montero MJ, Suarez-Artime P, Casas-Martinez A, Dominguez-Guerra M, Gonzalez-Freire L, Estany-Gestal A, Codero-Fort A, Rodriguez-Mañero M, Gonzalez-Juanatey JR, e investigadores MEMOGAL.

2022-02-033 citations

10.1016/j.arteri.2022.01.003

Interventions

DRUGPCSK9 inhibitor

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

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

Countries

Spain

Outcome results

None listed