NCT02891343

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

5.5 years

First QC Date

September 1, 2016

Last Update Submit

August 25, 2020

Conditions

Alteration of Cognitive FunctionHypoxia

Keywords

Cognitive FunctionHypoxiaNeurophysiological FunctionEffect of Alzheimer Disease symptomatic drugsHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The number of adverse events occuring during the period of hypoxia

    at the baseline and after the hypoxia session (day0)

Study Arms (1)

Healthy volunteers

EXPERIMENTAL
Other: 2-hour period of hypoxia

Interventions

2-hour period of hypoxiaOTHER

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.

Healthy volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA)
  • Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
  • Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
  • Subject with current chronic disease
  • Subject with vascular or metabolic risk factor
  • Subject with history of or current mental disease or addiction (MINI)
  • Subject with significant abnormality on biology
  • Subject with significant abnormality on ECG
  • Subject with significant abnormality on MRI
  • Subject with significant abnormality of electrical activities on EEG
  • Subject with family history of young onset dementia
  • Subject with family history of cardiac or pulmonary pathologies
  • Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
  • Subject with claustrophobia or contraindication to MRI
  • Subject under guardianship
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'Investigation Clinique, CHRU

Lille, France

NOT YET RECRUITING

Centre d'investigation Clinique

Marseille, France

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Régis Bordet

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Régis Bordet, MD,PhD

CONTACT

regis.bordet@univ-lille2.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)