Study on the utility of next-generation olfactometry in patients and at-risk subjects of Lewy body disease

JRCT ID: jRCTs041220064

Registered date:20/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lewy body disease (Parkinson's disease and dementia with Lewy bodies)
• Date of first enrollment: 12/10/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Provision of odor for evaluating olfactory function.

Outcome(s)

• Primary Outcome: Correlation between "Smell Test Device" and "Odor Stick (OSIT-J)"

Secondary Outcome

Discrimination ability for patients with Lewy body disease, at-risk subjects of Lewy body disease, and healthy controls
Correlation between "Smell Test Device" and other clinical scores and questionnaires

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(A) Patients with Lewy body disease (Parkinson's disease or dementia with Lewy bodies)
(1) Subjects whose age is 20 years old or more
(2) Subjects who fulfill MDS Clinical Diagnostic Criteria for PD (Clinically established PD) or criteria for the clinical diagnosis of probable and possible dementia with Lewy bodies (Probable DLB)
(3) Subjects who can make an outpatient visit
(4) Subjects or proxies who agree to participate in this study

(B) At-risk subjects of Lewy body disease
(1) Subjects whose age is 20 years old or more
(2) Subjects who have two or more prodromal symptoms:
SCOPA-AUT >= 10
OSIT-J <= 7 or SAOQ <= 90%
RBDSQ >= 5 or REM sleep without atonia (RWA) finding of polysomnography
(3) Subjects who are not diagnosed with Parkinson's disease or dementia with Lewy bodies
(4) Subjects who can make an outpatient visit
(5) Subjects who agree to participate in this study

(C) Healthy controls
(1) Subjects whose age is 20 years old or more
(2) Subjects who fulfill all of the following criteria:
SCOPA-AUT <= 9
SAOQ >= 90%
RBDSQ <= 4
(3) Subjects who are not diagnosed with Parkinson's disease or dementia with Lewy bodies
(4) Subjects who can make an outpatient visit
(5) Subjects who agree to participate in this study

Exclude criteria

(1) Subjects with severe hyposmia due to nasal disorders
(2) Subjects with severe heart disease (myocardial infarction, angina, etc.)
(3) Subjects with severe hepatic or renal dysfunction
(4) Subjects with mental or neurological disorders other than depression
(5) Subjects with other severe complications
(6) Female subjects who are pregnant or breast-feeding
(7) Subjects who disagree with contraception during the study period
(8) Subjects diagnosed with other neurological disorders using brain MRI at screening or before
(9) Subjects who are inappropriate to participate in the study
(10) Subjects who participate in other clinical trials. "Development of prodromal biomarkers with Parkinson's disease and dementia with Lewy bodies by analyzing body fluid and medical records" and "Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms (NaT-PROBE)" is excluded.

Related Information

• Primary Sponsor: Katsuno Masahisa
• Secondary Sponsor: Sony Corporation