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

Jose Seijas Amigo

Status: Completed

Conditions: Cognitive Function; Quality of Life; Hypercholesterolemia

Treatments: Drug: PCSK9 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT04319081

JSA-ALI-2019-01

2019/653 (Other Identifier)

PMID: 33941059 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

180 participants in 1 patient group

Uncontrolled patients with hypercholesterolemia

Description:

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

Treatment:

Drug: PCSK9 inhibitor