Computerized Olfactory Test - Alzheimer Disease Mild Stage

Not Applicable

Completed

• Conditions: Alzheimer Disease; Olfaction Disorders
• Interventions: Diagnostic Test: Olfactory test

• Registration Number: NCT03698760
• Lead Sponsor: Jewish General Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Study Start: 2019-06-25
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild stage Alzheimer group	Olfactory test	Participants with mild stage Alzheimer's disease
Control Group	Olfactory test	Participants without cognitive disorders

Primary Outcome Measures

Name	Time	Method
Objective test of evaluation of the olfactory sensitivity	15 minutes	olfactory test (only one evaluation): random fragrances, recognition (Yes or No)

Secondary Outcome Measures

Name	Time	Method
Objective test of evaluation of the olfactory thresholds	15 minutes	olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration
Health condition assessed by self-administered questionnaire (SAQ)	10 minutes	self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada