Clinical trial NCT04241042: Clinical Validation of the Bordeaux Maze Test
Official title: Clinical Validation of the Bordeaux Maze Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Healthy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Aelis Farma
First posted: 2020-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Validation of the Bordeaux Maze Test
timeFrame: Changes from months 0 to months 1 and 3
Secondary outcomes:
measure: Test retest reliability
timeFrame: months 0, 1 and 3
measure: Criteria validity
timeFrame: months 0, 1 and 3
measure: Analyses of the stability: Learning and practice effects observe on the Bordeaux Maze Test
timeFrame: months 0, 1 and 3
measure: Analyses of the stability: Learning and practice effects observe on the NIH Toolbox
timeFrame: months 0, 1 and 3
measure: Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test
timeFrame: months 0, 1 and 3
measure: Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox
timeFrame: months 0, 1 and 3
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)
Study officials:
References: