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Completed

NCT Number: NCT04319081

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

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.

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Key information

Conditions

Cognitive Function Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Virxen da Xunqueira de Cee, Cee, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCSK9 inhibitor

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. LDL-cholesterol values

    Time frame: 24 to 36 months

    LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)

  2. 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/

  3. Direct costs

    Time frame: 24 to 36 months

    Direct costs related with treatments and consultations (€)

Other outcomes

  1. Total Cholesterol

    Time frame: 24 to 36 months

    Total cholesterol evolution during the study in mg/dL

  2. Lp(a)

    Time frame: 24 to 36 months

    Lp(a) evolution during the study in mg/dL

  3. Cost-effectiveness

    Time frame: 24 to 36 months

    €/QUALY

Sponsors and collaborators

Lead sponsor

Jose Seijas Amigo

Other

Registry information

Official study title

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

Acronym: MEMOGAL

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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