Computerized Olfactory Test - Alzheimer Disease Mild Stage

NCT03698760 | Completed

• 1 other identifier: 2019-1509
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease; Olfaction Disorders

Outcome Measures

Primary Outcomes (1)

• Objective test of evaluation of the olfactory sensitivity

  olfactory test (only one evaluation): random fragrances, recognition (Yes or No)

  15 minutes

Secondary Outcomes (2)

• Health condition assessed by self-administered questionnaire (SAQ)

  10 minutes

• Objective test of evaluation of the olfactory thresholds

  15 minutes

Study Arms (2)

Mild stage Alzheimer group

EXPERIMENTAL

Participants with mild stage Alzheimer's disease

Diagnostic Test: Olfactory test

Control Group

EXPERIMENTAL

Participants without cognitive disorders

Diagnostic Test: Olfactory test

Interventions

Olfactory test 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; Mild stage Alzheimer group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Olfaction Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Beauchet, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Geriatrics

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: June 25, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CA (1)