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Clinical Validation of the Bordeaux Maze Test (BORMATE)

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: NCT04241042
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Aelis Farma
Information provided by (Responsible Party):
Parc de Salut Mar

Brief Summary:
Currently, the instruments used in translational studies related to cognition have proved to be inaccurate. For this reason, the objective of this study is to evaluate whether the Bordeaux Maze Test has adequate psychometric properties and is valid for its use to compare trials tested in preclinical (animal) studies and clinical population with Down syndrome. Specifically, it is intended to study the domains of memory (relational memory) and executive functions (work memory), both relevant in the cognitive functioning of the population with Down syndrome.

Condition or disease
Down Syndrome Healthy

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Validation of the Bordeaux Maze Test
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Group/Cohort
Down syndrome volunteers
Males and females from 16 to 35 years
Healthy volunteers
Males and females from 18 to 35 years



Primary Outcome Measures :
  1. Validation of the Bordeaux Maze Test [ Time Frame: Changes from months 0 to months 1 and 3 ]
    To validate a novel neuropsychological test, the Bordeaux Maze Test for the evaluation of working memory in subjects with Down syndrome (DS)


Secondary Outcome Measures :
  1. Test retest reliability [ Time Frame: months 0, 1 and 3 ]
    To validate the Bordeaux Maze Test, for the evaluation of cognitive flexibility in subjects with Down syndrome (DS)

  2. Criteria validity [ Time Frame: months 0, 1 and 3 ]
    To evaluate the influence of age and gender on the Bordeaux Maze Test in the Down syndrome population;

  3. Analyses of the stability: Learning and practice effects observe on the Bordeaux Maze Test [ Time Frame: months 0, 1 and 3 ]
    To evaluate the relevance of learning/practice effects

  4. Analyses of the stability: Learning and practice effects observe on the NIH Toolbox [ Time Frame: months 0, 1 and 3 ]
    To evaluate the relevance of learning/practice effects

  5. Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test [ Time Frame: months 0, 1 and 3 ]
    To evaluate the relevance of floor/ceiling effects

  6. Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox [ Time Frame: months 0, 1 and 3 ]
    To evaluate the relevance of floor/ceiling effects


Biospecimen Retention:   Samples Without DNA
Endocannabinoid content


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:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Down syndrome volunteers are recruited from Down syndrome foundations and control volunteers from educational centres nearby the research institute.
Criteria

Inclusion Criteria:

  • Down syndrome population:

    • Males and females aged 16 to 35 years.
    • Clinical diagnosis of DS (full trisomy 21 or translocated) confirmed by chromosomal analysis (karyotyping).
    • Parent or legal guardian/representative and caregiver willing to give written informed consent.
    • Study participants must have sufficient vision and hearing to participate in study evaluations. Mild hearing loss will be allowed.
    • Availability of parent/caregiver to accompany the subject to clinical visits.
    • Subjects must be able to understand basic instructions.
    • Parent or legal guardian/representative and caregiver willing to give written informed consent
  • Normotypical population:

    • Males and females aged 18 to 35 years.
    • Clinical history and physical examination demonstrating no organic or psychiatric disorders.
    • Understanding and accepting the study procedures and signing the informed consent.

Exclusion Criteria:

  • Study participants with a current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of any primary or secondary psychiatric diagnoses (such as autism spectrum disorder, attention deficit hyperactivity disorder, depression and conduct disorder). Participation are allowed as long as they are considered stable and their medication with a regime that does not change in the 6 weeks prior to enrolment and does not interfere with the progression of the study.
  • Subjects with evidence of dementia or meeting clinical diagnoses for dementia.
  • Subjects thyroid dysfunction or diabetes that is not adequately controlled or stabilized on treatment for at least 8 weeks prior to randomization.
  • Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure.
  • Subjects with past history of seizures from primary causes (such as West syndrome and Lennox-Gastaut syndrome) or secondary causes.
  • Clinical history of moderate or severe Obstructive Sleep Apnea (OSA) as defined by Apnea-Hypopnea Index (AHI) (>15 events per hour not well controlled by positive airway pressure therapy with stable settings) for at least 3 months prior to screening visit.
  • Alcohol and/or substance use disorder in the past year.
  • Concomitant disease or condition or any clinically significant finding at screening that could interfere with the conduct of the study, or that would, in the opinion of the investigator, could lead to an unacceptable risk to the subject in this study.
  • Participation in other clinical trials in the last 3 months prior to the study.

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): NCT04241042


Contacts
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Contact: Rafael de la Torre, Prof +34933160484 rtorre@imim.es

Locations
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Spain
IMIM (Institut Hospital del Mar d'Investigacions Mèdiques) Recruiting
Barcelona, Spain, 08003
Contact: Rafael De la Torre Fornell, PhD    0034933160484    rtorre@imim.es   
Principal Investigator: Rafael de la Torre, PhD         
Sponsors and Collaborators
Parc de Salut Mar
Aelis Farma

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04241042    
Other Study ID Numbers: BORMATE/2
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Down Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn