An observational study in Cognitive Function, Hypercholesterolemia and Quality of Life, sponsored by Jose Seijas Amigo. Completed at 12 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Jose Seijas Amigo · Observational
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 180 is below the median of 800 across 185 observational studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Jose Seijas Amigo is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
Changes in cognitive function
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.
Time frame: 24 to 36 months
LDL-cholesterol values
LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)
Time frame: 24 to 36 months
Changes in Quality of life
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/
Time frame: 24 to 36 months
Direct costs
Direct costs related with treatments and consultations (€)
Time frame: 24 to 36 months
Total Cholesterol
Total cholesterol evolution during the study in mg/dL
Time frame: 24 to 36 months
Lp(a)
Lp(a) evolution during the study in mg/dL
Time frame: 24 to 36 months
Cost-effectiveness
€/QUALY
Time frame: 24 to 36 months
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Jose Seijas Amigo