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

January 13, 2023 updated by: Jose Seijas Amigo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de A Coruña
      • Lugo, Spain
        • Hospital Lucus-Augusti de Lugo
      • Ourense, Spain
        • Complejo Hospitalario Universitario de Ourense
      • Pontevedra, Spain
        • Complexo Hospitalario Universitario de Pontevedra
    • A Coruña
      • Cee, A Coruña, Spain
        • Hospital de Virxen da Xunqueira de Cee
      • Ferrol, A Coruña, Spain
        • Hospital Arquiteto Marcide de Ferrol
      • Ribeira, A Coruña, Spain
        • Hospital del Barbanza
      • Santiago De Compostela, A Coruña, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
    • Lugo
      • Burela, Lugo, Spain
        • Hospital Público da Mariña de Burela
      • Monforte De Lemos, Lugo, Spain
        • Hospital de Monforte
    • Ourense
      • O Barco De Valdeorras, Ourense, Spain
        • Hospital do Barco de Valdeorras
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Hospital Alvaro Cunqueiro de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with familial hypercholesterolemia (homozygous and heterozygous) and/or cardiovascular disease with LDL-cholestrol value > 100 mg/dL and maximum statine doses or intolerance. With a first prescription of PCSK9 inhibitors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 to 36 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Seijas Amigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 13, 2023

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSA-ALI-2019-01
  • 2019/653 (Other Identifier: CEIm-G)
  • PMID: 33941059 (Other Identifier: pubmed)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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