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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02891343
Other study ID # 2013_44
Secondary ID 2014-A00513-44
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date May 2021

Study information

Verified date August 2020
Source University Hospital, Lille
Contact Régis Bordet, MD,PhD
Email regis.bordet@univ-lille2.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
2-hour period of hypoxia
During this period, the FiO2 will be set on 21% (normoxia condition). A filter will be put between the mask and the tubes connecting it to the machine generating hypoxia (equipment reference = Altitrainer NP190). On that filter a gas analyser will monitor the FiO2 and a capnography monitor (Capnostream 20, ORIDION) will also be installed.

Locations

Country Name City State
France Centre d'Investigation Clinique, CHRU Lille
France Centre d'investigation Clinique Marseille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery Between baseline (normoxic period) and Day 0 (hypoxia session )
Secondary The number of adverse events occuring during the period of hypoxia at the baseline and after the hypoxia session (day0)
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