Clinical trial NCT02891343: Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers
Official title: Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alteration of Cognitive Function
Hypoxia
Keywords: Cognitive Function
Hypoxia
Neurophysiological Function
Effect of Alzheimer Disease symptomatic drugs
Healthy Subjects
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.


Eligibility criteria: Inclusion Criteria:

* Good health on the basis of the medical interview, physical examination and standard biology parameters.
* Right-Handed
* Non-smoker
* No cardiac nor pulmonary pathologies
* No use of chronic treatment or psychotropic drugs or substances
* BMI inferior to 25 Kg/m2
* French speaker and able to understand the test instructions
* Informed consent form signed

Exclusion Criteria:

1. Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor...) or retinal pathologies (including familial DMLA)
2. Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
3. Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
4. Subject with current chronic disease
5. Subject with vascular or metabolic risk factor
6. Subject with history of or current mental disease or addiction (MINI)
7. Subject with significant abnormality on biology
8. Subject with significant abnormality on ECG
9. Subject with significant abnormality on MRI
10. Subject with significant abnormality of electrical activities on EEG
11. Subject with family history of young onset dementia
12. Subject with family history of cardiac or pulmonary pathologies
13. Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
14. Subject with claustrophobia or contraindication to MRI
15. Subject under guardianship
16. Subject not covered by Social Security
17. Subject participating in another clinical trial
18. Subject with anxiety (STAI-Trait Score T\> 51) or neuroticism personality (EPI Score N ≥13)
19. Subject bearded or refusing to shave

Primary outcomes:
measure: the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery
timeFrame: Between baseline (normoxic period) and Day 0 (hypoxia session )
Secondary outcomes:
measure: The number of adverse events occuring during the period of hypoxia
timeFrame: at the baseline and after the hypoxia session (day0)
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre d'Investigation Clinique, CHRU
city: Marseille
country: France
facility: Centre d'investigation Clinique
Study officials:
affiliation: University Hospital, Lille
name: Régis Bordet
role: PRINCIPAL_INVESTIGATOR
References: