Investigation for efficacy and safety of [18F] SPAL-T-06

JRCT ID: jRCTs031210180

Registered date:02/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dementia with Lewy bodies, Parkinson's disease, and multiple system atrophy
• Date of first enrollment: 29/07/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Injection of [18F]SPAL-T-06 and PET scan

Outcome(s)

Primary Outcome

(A) Brain dynamics evaluation
Efficacy evaluation: Quantitative evaluation of the brain dynamics of [18F] SPAL-T-06 and the extent and distribution of alpha-synuclein lesions in patients with dementia with Lewy bodies, Parkinson's disease, multiple system atrophy, and healthy volunteers.
Safety evaluation: Changes in subjective symptoms, other findings, and laboratory tests after [18F] SPAL-T-06 administration.
(B) Whole body dynamic evaluation
Efficacy evaluation: Distribution test of [18F] SPAL-T-06 in the whole body.
Safety evaluation: Effective dose per unit dose of radiation of [18F] SPAL-T-06. Changes in subjective symptoms, other findings, and laboratory tests after [18F] SPAL-T-06 administration.

Secondary Outcome

(A) Brain dynamics evaluation
In patients with dementia with Lewy bodies, Parkinson's disease, multiple system atrophy, and healthy volunteers, we will explore the relationship between (1) the extent and distribution of alpha-synuclein lesions assessed by PET using [18F] SPAL-T-06, (2) abnormal protein accumulation in the brain assessed by PET using [11C]PiB (2) Brain accumulation of abnormal proteins assessed by PET using [11C]PiB, (3) Brain structure and neurotransmission function assessed by MRI data, (4) Correlation between blood data and clinical symptom scores. (2)-(4) will also be evaluated using existing data.

Key inclusion & exclusion criteria

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

Include criteria

(A) Brain dynamics evaluation
Patients (6 patients with dementia with Lewy bodies, 6 patients with Parkinson's disease, and 6 patients with multiple system atrophy)
(1) Patients who are 20 years old or older at the time of consent acquisition.
(2) Patients whom a potential substitute can accompany on the day of participation in the study at NIRS.
(3) Patients with dementia with Lewy bodies and Parkinson's disease: Patients who meet the UK Parkinson's disease society brain bank clinical diagnostic criteria or the diagnostic criteria of McKeith et al.
(4) Patients with multiple system atrophy: Patients who meet Gilman's clinical diagnosis criteria for MSA.

Healthy subjects (6 Healthy subjects)
(1) Healthy adults who have been determined to be eligible for this study by the principal investigator or sub-investigator.
(2) Those who are 20 years of age or older at the time of obtaining consent.

(B) Whole body dynamic evaluation (6 Healthy subjects; 3 male and 3 female)
(1) Healthy adults who are judged to be eligible for this study by a medical examination by the principal investigator or sub-investigator.
(2) Healthy adults who are 50 years of age or older at the time consent is obtained.

Exclude criteria

(1) Patients with a history of or complications from organic brain disease (for example, disorders of consciousness, head trauma requiring hospitalization, evident cerebral infarction, or cerebral hemorrhage).
(2) Patients with substance-related disorders (for example, drug dependence).
(3) Those who have complications from serious diseases or those who have a history of such diseases, judged by the principal investigator or sub-investigator to be inappropriate for this study.
(4) Those who have magnetic metals in their body (for example, tattoos, tattoos including art makeup, pacemakers) (for brain dynamics evaluation only).
(5) Persons with intense claustrophobia.
(6) Those who are pregnant or may be pregnant, and those who are breast-feeding.
(7) Those who are allergic to local anesthetics and blood coagulation inhibitors. (Brain dynamics evaluation only)
(8) Those who are taking the anticoagulant medication. (Brain dynamics evaluation only)
(9) Others judged by the principal investigator or sub-investigator to be inappropriate as research subjects.

Related Information

• Primary Sponsor: Endo Hironobu
• Secondary Sponsor: Higuchi Makoto
• Source(s) of Monetary Support: Eisai Co., Ltd.,Neuroscience Drug Discovery Unit, Research, Takeda Pharmaceutical Company Limited,Ono Pharmaceutical Co. Ltd