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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319081
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jose Seijas Amigo, Hospital Clinico Universitario de Santiago

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
Cognitive Function Hypercholesterolemia Quality of Life Drug: PCSK9 inhibitor

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Study Type : Observational
Estimated Enrollment : 275 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 : March 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319081


Contacts
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Contact: Jose Seijas Amigo, Pharmacist 981955764 jose.seijas.amigo@gmail.com

Locations
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Spain
Hospital de Virxen da Xunqueira de Cee Recruiting
Cee, A Coruña, Spain
Contact: Jose Luis Rodriguez Sanchez         
Principal Investigator: Jose Luis Rodriguez Sanchez         
Hospital Arquiteto Marcide de Ferrol Recruiting
Ferrol, A Coruña, Spain
Contact: Antonia Casas Martinez         
Principal Investigator: Antonia Casas Martinez         
Hospital del Barbanza Recruiting
Ribeira, A Coruña, Spain
Contact: Hector Mozo Peñalver         
Principal Investigator: Hector Mozo Peñalver         
Sub-Investigator: Esther Espino Paisán         
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago De Compostela, A Coruña, Spain
Contact: Jose Seijas Amigo, Pharmacist    +34981955764    jose.seijas.amigo@sergas.es   
Contact: Pedro Suarez Artime, Pharmacist       pedro.suarez.artime@sergas.es   
Principal Investigator: Jose Seijas Amigo         
Principal Investigator: Pedro Suarez Artime         
Sub-Investigator: Diego Rodriguez Penas         
Sub-Investigator: Jose Ramon Gonzalez Juanatey         
Sub-Investigator: Irene Zarra Ferro         
Hospital Público da Mariña de Burela Recruiting
Burela, Lugo, Spain
Contact: Concepción Castro Rubiños         
Principal Investigator: Concepción Castro Rubiños         
Hospital de Monforte Recruiting
Monforte De Lemos, Lugo, Spain
Contact: Laura Villaverde Piñeiro         
Principal Investigator: Laura Villaverde Piñeiro         
Hospital do Barco de Valdeorras Recruiting
O Barco De Valdeorras, Ourense, Spain
Contact: Ana Rodriguez Vazquez         
Principal Investigator: Ana Rodriguez Vazquez         
Hospital Alvaro Cunqueiro de Vigo Recruiting
Vigo, Pontevedra, Spain
Contact: Monica Gayoso Rey         
Principal Investigator: Monica Gayoso Rey         
Sub-Investigator: Karina Lorenzo Lorenzo         
Sub-Investigator: María del Mar Lopez-Gil Otero         
Complejo Hospitalario Universitario de A Coruña Recruiting
A Coruña, Spain, 15706
Contact: María Jose Mauriz Montero         
Principal Investigator: María Jose Mauriz Montero         
Sub-Investigator: Luis Margusino Framiñan         
Hospital Lucus-Augusti de Lugo Recruiting
Lugo, Spain
Contact: Natalia Perez Rodriguez         
Principal Investigator: Natalia Perez Rodriguez         
Sub-Investigator: María Anido García         
Complejo Hospitalario Universitario de Ourense Recruiting
Ourense, Spain
Contact: María Dominguez Guerra         
Principal Investigator: María Dominguez Guerra         
Complexo Hospitalario Universitario de Pontevedra Recruiting
Pontevedra, Spain
Contact: Carlos Crespo Diz         
Principal Investigator: Carlos Crespo Diz         
Sub-Investigator: Lara Gonzalez Freire         
Sponsors and Collaborators
Jose Seijas Amigo
Additional Information:
Publications:

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Responsible Party: Jose Seijas Amigo, Pharmacist, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT04319081    
Other Study ID Numbers: JSA-ALI-2019-01
2019/653 ( Other Identifier: CEIm-G )
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Seijas Amigo, Hospital Clinico Universitario de Santiago:
Cognitive Function
Hypercholesterolemia
Quality of Life
Pharmacoeconomics
PCSK9 inhibitors
Alirocumab
Evolocumab
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases