Computerized Olfactory Test - Alzheimer Disease Mild Stage

NCT ID: NCT03698760

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2020-03-05

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.

Conditions

Alzheimer Disease; Olfaction Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mild stage Alzheimer group

Participants with mild stage Alzheimer's disease

Group Type: EXPERIMENTAL

Olfactory test

Intervention Type: DIAGNOSTIC_TEST

Olfactory test:

All fragrances tested are kept in an airtight case protected from cold and heat.

The test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way.

Control Group

Participants without cognitive disorders

Group Type: EXPERIMENTAL

Olfactory test

Intervention Type: DIAGNOSTIC_TEST

Olfactory test:

All fragrances tested are kept in an airtight case protected from cold and heat.

The test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way.

Interventions

Olfactory test

Olfactory test:

All fragrances tested are kept in an airtight case protected from cold and heat.

The test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way.

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olivier Beauchet

Professor of Geriatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Beauchet, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2019-1509

Identifier Type: -

Identifier Source: org_study_id