Computerized Olfactory Test - Alzheimer Disease Mild Stage
Primary Purpose
Alzheimer Disease, Olfaction Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Olfactory test
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Disease
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).
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mild stage Alzheimer group
Control Group
Arm Description
Participants with mild stage Alzheimer's disease
Participants without cognitive disorders
Outcomes
Primary Outcome Measures
Objective test of evaluation of the olfactory sensitivity
olfactory test (only one evaluation): random fragrances, recognition (Yes or No)
Secondary Outcome Measures
Health condition assessed by self-administered questionnaire (SAQ)
self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
Objective test of evaluation of the olfactory thresholds
olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03698760
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Olfaction Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild stage Alzheimer group
Arm Type
Experimental
Arm Description
Participants with mild stage Alzheimer's disease
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Participants without cognitive disorders
Intervention Type
Diagnostic Test
Intervention Name(s)
Olfactory test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective test of evaluation of the olfactory sensitivity
Description
olfactory test (only one evaluation): random fragrances, recognition (Yes or No)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Health condition assessed by self-administered questionnaire (SAQ)
Description
self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
Time Frame
10 minutes
Title
Objective test of evaluation of the olfactory thresholds
Description
olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Beauchet, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
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Computerized Olfactory Test - Alzheimer Disease Mild Stage
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