Clinical trial NCT03698760: Computerized Olfactory Test - Alzheimer Disease Mild Stage
Official title: Calibration and Validation of a Computerized Olfactory Test in Subjects With Alzheimer's Disease in a Mild Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Olfaction Disorders
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a single-center controlled study (Jewish General Hospital, Montreal, Quebec, Canada), consisting of two groups of subjects: a control group and a group of subjects with mild Alzheimer's disease.
Primary purpose: OTHER

Brief summary: This study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.

Detailed description: For twenty years research has shown a strong link between olfactory disorders and Alzheimer's disease. The focus is on the very early alteration of the olfaction which acts as a harbinger of the disease since it is detectable in its asymptomatic phase. In addition, olfactory involvement is a precursor to the transformation of mild cognitive impairment into MA. Indeed the anatomical structures the first lesions are located in the transentorhinal region of the temporal lobe and entorhinal phase, before progressing towards the limbic system, which will mark the clinical appearance of the first signs of AD.

In literature, it has been shown that there was no olfactory test that is recognized as a gold standard in the scientific community due to a lack of homogeneity of the tools used, their availability and their validity depending on the culture. Moreover, of all the tests currently available, none are specific to neurodegenerative diseases.

Very recent studies show that there is also a strong preference for imaging tools or biomarkers in the detection of AD, but it appears that the olfactory disorders are well before these markers. It has been shown that an identification test is comparable in predictive accuracy to neuroimaging and cerebrospinal fluid sampling.

This study will therefore focus on the calibration and validation of a computerized olfactory test for the diagnosis of Alzheimer's disease and based the recommendations of professionals so as to promote the effective use of this test in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Being 60 years old and over
* The participants enrolled in the control group must have a score of the Mini-Mental State Exam test greater than or equal to 28.
* The participants enrolled in the intervention group must have a diagnosis of Alzheimer's disease, and the score of the Mini-Mental State Exam test should be between 20 and 27

Exclusion Criteria:

* Presenting an unstable, acute or current psychiatric or physical condition that is severe enough to prevent the participant from participating in the study, as determined by the investigator.
* Having an uncorrected major visual or hearing impairment or anosmia (total olfaction loss).

Primary outcomes:
measure: Objective test of evaluation of the olfactory sensitivity
timeFrame: 15 minutes
Secondary outcomes:
measure: Health condition assessed by self-administered questionnaire (SAQ)
timeFrame: 10 minutes
measure: Objective test of evaluation of the olfactory thresholds
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References: