Healthy Person/Mild Cognitive Impairment/Alzheimer'
Conditions
Interventions
Subjects will be tested for olfaction using a total of 20 research substances including 10 fragrances and 2 concentrations each.
Sponsors
Kobayashi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the inclusion criteria will be enrolled in this study. 1) Men and women between 40 and 90 years-old at the time of obtaining consent. 2) Subjects who meets any of the following criteria A) Healthy volunteers: Subjects with a MMSE score of 28 or higher B) Mild cognitive impairment: Subjects with a MMSE score of 24 or higher and 27 or lower who diagnosed with mild cognitive impairment and with dysmnesia by a dementia specialist based on the diagnostic criteria of Petersen et al. C) Alzheimer's disease: Subjects with a MMSE score of 23 or lower who diagnosed with Alzheimer's disease by a dementia specialist based on one of the following items; ICD-10, DSM-5, and NIA-AA. 3) Subjects have no olfactory impairment who judged by a physician to be able to adequately describe their subjective symptoms and olfactory scores 4) Subjects who obtained written informed consent (informed consent from proxy for AD patients only).
Exclusion criteria
Exclusion criteria: Subjects who meet any of the exclusion criteria will not be enrolled in this study. 1) Subjects who have had an allergic reaction to a fragrance in the past. 2) Pregnant women or subjects who wish to become pregnant. 3) Subjects diagnosed with an olfactory disorder with a definite cause. 4) Subjects with epilepsy or who have a history of epilepsy. 5) Subjects with depression and other psychiatric disorders or who have a history of those. 6) Subjects who have taken a test such as MMSE or MoCA-J within one month of the date of obtaining consent. 7) Subjects who are expected to have a significant effect on the following olfactory functions. - Subjects who reported smoking on the day of the olfactometry. - Subjects who reported on the day of the olfactometry that they were concerned about olfactory dysfunction such as hay fever, rhinitis, or chronic sinusitis. - Subjects who reported using the perfume on the day of the olfactometry. - Subjects who reported consuming strongly smelling food from the day before to the day of the olfactometry. 8) Subjects who are bedridden or unconscious and determined to have severe Alzheimer's disease. 9) Current smoker. 10) Subjects who have been judged by the principal investigator or sub-investigator to be inappropriate for this study, in addition to the reasons listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The relationship between cognitive impairment and olfactory deficits in subjects with healthy, mild cognitive impairment, and Alzheimer's disease. 1) Olfactory score by disease level 2) The relationship between olfactory scores and cognitive functioning indicators 3) Discriminability of disease levels using olfactory scores | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The ability to diagnose disease levels using olfactory scores 2) Subgroup analysis by medical history and comorbidity | — |
Countries
Japan
Contacts
Public ContactKensuke Fujimoto
Mebix, Inc. Research Promotion Group
Outcome results
None listed