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Cognitive FunctionMEMOGALNCT04319081

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

An observational study of Cognitive Function and Hypercholesterolemia, run by Jose Seijas Amigo at 12 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PCSK9 inhibitor
How many people
180 participants
Where
12 sitesSpain
Study dates
1 Mar 2020to 13 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Diagnosis of any disease related with cognitive deterioration

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, 15706

  • Hospital Público da Mariña de Burela

    Burela de Cabo, Lugo

  • Hospital de Virxen da Xunqueira de Cee

    Cee, A Coruña

  • Hospital Arquiteto Marcide de Ferrol

    Ferrol, A Coruña

  • Hospital Lucus-Augusti de Lugo

    Lugo

  • Hospital de Monforte

    Monforte de Lemos, Lugo

  • Hospital do Barco de Valdeorras

    O Barco de Valdeorras, Ourense

  • Complejo Hospitalario Universitario de Ourense

    Ourense

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra

  • Hospital del Barbanza

    Ribeira, A Coruña

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Hospital Alvaro Cunqueiro de Vigo

    Vigo, Pontevedra

Other trials in Spain

About this study

Official title: 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.

Being tested
PCSK9 inhibitor
Keywords
Cognitive Function, Hypercholesterolemia, Quality of Life, Pharmacoeconomics, PCSK9 inhibitors, Alirocumab, Evolocumab
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCSK9 inhibitorDrug

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

Study groups in NCT04319081
Study groupRoleWhat they receive
Uncontrolled patients with hypercholesterolemiaPatients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab
Receives: Drug: PCSK9 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 to 36 months

Secondary outcomes (3)

  1. LDL-cholesterol values

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

    Measured: 24 to 36 months

  2. 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/

    Measured: 24 to 36 months

  3. Direct costs

    Direct costs related with treatments and consultations (€)

    Measured: 24 to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start1 Mar 2020
  3. Primary completion31 Dec 2022
  4. Study completion13 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319081
Sponsor's protocol ID
JSA-ALI-2019-01
Other IDs
2019/653, PMID: 33941059
Acronym
MEMOGAL
Status last verified
Jan 2023
First submitted
20 Mar 2020
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.

    PubMed 28813214

  • Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097-2107. doi: 10.1056/NEJMoa1801174. Epub 2018 Nov 7.

    PubMed 30403574

  • Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

    PubMed 28304224

  • Kolodziejczak M, Navarese EP. Role of PCSK9 antibodies in cardiovascular disease: Critical considerations of mortality and neurocognitive findings from the current literature. Atherosclerosis. 2016 Apr;247:189-92. doi: 10.1016/j.atherosclerosis.2016.02.011. Epub 2016 Feb 15.

    PubMed 26926598

  • Lipinski MJ, Benedetto U, Escarcega RO, Biondi-Zoccai G, Lhermusier T, Baker NC, Torguson R, Brewer HB Jr, Waksman R. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016 Feb 7;37(6):536-45. doi: 10.1093/eurheartj/ehv563. Epub 2015 Nov 17.

    PubMed 26578202

  • Shibata N, Ohnuma T, Higashi S, Higashi M, Usui C, Ohkubo T, Watanabe T, Kawashima R, Kitajima A, Ueki A, Nagao M, Arai H. No genetic association between PCSK9 polymorphisms and Alzheimer's disease and plasma cholesterol level in Japanese patients. Psychiatr Genet. 2005 Dec;15(4):239. doi: 10.1097/00041444-200512000-00004. No abstract available.

    PubMed 16314752

  • Xue-Shan Z, Juan P, Qi W, Zhong R, Li-Hong P, Zhi-Han T, Zhi-Sheng J, Gui-Xue W, Lu-Shan L. Imbalanced cholesterol metabolism in Alzheimer's disease. Clin Chim Acta. 2016 May 1;456:107-114. doi: 10.1016/j.cca.2016.02.024. Epub 2016 Mar 2.

    PubMed 26944571

  • Banach M, Rizzo M, Nikolic D, Howard G, Howard V, Mikhailidis D. Intensive LDL-cholesterol lowering therapy and neurocognitive function. Pharmacol Ther. 2017 Feb;170:181-191. doi: 10.1016/j.pharmthera.2016.11.001. Epub 2016 Nov 16.

    PubMed 27865998

  • Paquette M, Saavedra YGL, Poirier J, Theroux L, Dea D, Baass A, Dufour R. Loss-of-Function PCSK9 Mutations Are Not Associated With Alzheimer Disease. J Geriatr Psychiatry Neurol. 2018 Mar;31(2):90-96. doi: 10.1177/0891988718764330. Epub 2018 Mar 21.

    PubMed 29562810

  • Robinson JG, Rosenson RS, Farnier M, Chaudhari U, Sasiela WJ, Merlet L, Miller K, Kastelein JJ. Safety of Very Low Low-Density Lipoprotein Cholesterol Levels With Alirocumab: Pooled Data From Randomized Trials. J Am Coll Cardiol. 2017 Feb 7;69(5):471-482. doi: 10.1016/j.jacc.2016.11.037.

    PubMed 28153102

  • Seijas-Amigo J, Rodriguez-Penas D, Estany-Gestal A, Suarez-Artime P, Santamaria-Cadavid M, Gonzalez-Juanatey JR. Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol. Farm Hosp. 2021 Mar 5;45(3):150-154. doi: 10.7399/fh.11569.

    PubMed 33941059

  • Seijas-Amigo J, Gayoso-Rey M, Mauriz-Montero MJ, Suarez-Artime P, Casas-Martinez A, Dominguez-Guerra M, Gonzalez-Freire L, Estany-Gestal A, Codero-Fort A, Rodriguez-Manero M, Gonzalez-Juanatey JR; e investigadores MEMOGAL. Impact of the COVID-19 pandemic in the lipid control of the patients that start PCSK9 inhibitors. Clin Investig Arterioscler. 2022 Sep-Oct;34(5):245-252. doi: 10.1016/j.arteri.2022.01.003. Epub 2022 Feb 3. English, Spanish.

    PubMed 35287972

  • Seijas-Amigo J, Mauriz-Montero MJ, Suarez-Artime P, Gayoso-Rey M, Reyes-Santias F, Estany-Gestal A, Casas-Martinez A, Gonzalez-Freire L, Rodriguez-Vazquez A, Perez-Rodriguez N, Villaverde-Pineiro L, Castro-Rubinos C, Espino-Paisan E, Cordova-Arevalo O, Rodriguez-Penas D, Cardeso-Paredes B, Ribeiro-Ferreiro M, Rodriguez-Manero M, Cordero A, Gonzalez-Juanatey JR, Memogal Investigators. Cost-Utility Analysis of PCSK9 Inhibitors and Quality of Life: A Two-Year Multicenter Non-Randomized Study. Diseases. 2024 Oct 5;12(10):244. doi: 10.3390/diseases12100244.

    PubMed 39452487

  • Seijas-Amigo J, Mauriz-Montero MJ, Suarez-Artime P, Gayoso-Rey M, Estany-Gestal A, Casas-Martinez A, Gonzalez-Freire L, Rodriguez-Vazquez A, Perez-Rodriguez N, Villaverde-Pineiro L, Castro-Rubinos C, Espino-Faisan E, Rodriguez-Manero M, Cordero A, Gonzalez-Juanatey JR; Investigadores MEMOGAL. Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study. Am J Cardiovasc Drugs. 2023 Sep;23(5):583-593. doi: 10.1007/s40256-023-00604-6. Epub 2023 Aug 23.

    PubMed 37612529

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Function and Hypercholesterolemia, run by Jose Seijas Amigo at 12 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cognitive function (time frame: 24 to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04319081, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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