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

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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

Tracking Information
First Submitted Date March 20, 2020
First Posted Date March 24, 2020
Last Update Posted Date June 2, 2020
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2020)
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.
Original Primary Outcome Measures
 (submitted: March 20, 2020)
Changes in cognitive function [ Time Frame: 24 to 36 months ]
Assesment by MOCA questionarie (Montreal Cognitive Assessment) (0-30)
Change History
Current Secondary Outcome Measures
 (submitted: March 24, 2020)
  • LDL-cholesterol values [ Time Frame: 24 to 36 months ]
    LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)
  • 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/
  • Direct costs [ Time Frame: 24 to 36 months ]
    Direct costs related with treatments and consultations (€)
Original Secondary Outcome Measures
 (submitted: March 20, 2020)
  • LDL-cholesterol values [ Time Frame: 24 to 36 months ]
    LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)
  • Changes in Quality of life [ Time Frame: 24 to 36 months ]
    By EQ-5D-3L assessment (EVA 1,0000 to -0,6533)
  • Direct costs [ Time Frame: 24 to 36 months ]
    Direct costs related with treatments and consultations (€)
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2020)
  • Total Cholesterol [ Time Frame: 24 to 36 months ]
    Total cholesterol evolution during the study in mg/dL
  • Lp(a) [ Time Frame: 24 to 36 months ]
    Lp(a) evolution during the study in mg/dL
  • Cost-effectiveness [ Time Frame: 24 to 36 months ]
    €/QUALY
Original Other Pre-specified Outcome Measures
 (submitted: March 20, 2020)
  • Total Cholesterol [ Time Frame: 24 to 36 months ]
    Total cholestrol evolution during the sutdy in mg/dL
  • Lp(a) [ Time Frame: 24 to 36 months ]
    Lp(a) evolution during the sutdy in mg/dL
  • Cost-effectiveness [ Time Frame: 24 to 36 months ]
    €/QUALY
 
Descriptive Information
Brief Title Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors
Official Title Multicenter, Observational and Prospective Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors (MEMOGAL)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Cognitive Function
  • Hypercholesterolemia
  • Quality of Life
Intervention Drug: PCSK9 inhibitor
Patients are included after PCSK9 inhibitors prescription , at the first dispensation
Study Groups/Cohorts Uncontrolled patients with hypercholesterolemia
Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab
Intervention: Drug: PCSK9 inhibitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2020)
275
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2023
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jose Seijas Amigo, Pharmacist 981955764 jose.seijas.amigo@gmail.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04319081
Other Study ID Numbers JSA-ALI-2019-01
2019/653 ( Other Identifier: CEIm-G )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Jose Seijas Amigo, Hospital Clinico Universitario de Santiago
Study Sponsor Jose Seijas Amigo
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospital Clinico Universitario de Santiago
Verification Date June 2020