Alzheimer's Disease, Mild Cognitive Impairment, Neurodegenerative Diseases
Conditions
Keywords
Tau, neurodegeneration, positron emission computed tomography
Brief summary
This is a cross-sectional and longitudinal study to evaluate the clinical utility of \[18F\]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.
Interventions
DRUG[18F]THK-5351
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Sponsors
Korea Health Industry Development Institute
Samsung Medical Center
Jae Seung Kim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. General Subject Inclusion Criteria In order to be eligible for participation in this trial, the subject must: * Be ≥ 40 and \< 80 years of age at the Screening Visit. * Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.) * Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test. * Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to \[18F\]THK-5351 positron emission computed tomography) or clinically acceptable to the investigator at screening. * Be able to possess the ability to respond verbally to questions, follow instructions, and underwent research assessment, including brain images based on the investigator's judgment. Each subject is also able and willing to adhere visit schedules. * If female, not be of childbearing potential as indicated by one of the following * Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments. * Each subject must be willing to provided blood samples for genotyping apolipoprotein E 2. Cognitively Healthy Subjects 3. MCI Subjects 4. AD Subjects 5. Subjects with other neurodegenerative disease
Exclusion criteria
The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below: 1\. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional [18F]THK-5351 Imaging Results | 50-70 minutes post injection | Compare Standard uptake value ratio (SUVR) and distribution of \[18F\]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals. |
| Assess the rate of change of tau deposition as measured by [18F]THK-5351 uptake (SUVR) over time | 24 months | Compare Standard uptake value ratio (SUVR) and distribution of \[18F\]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and neuropsychiatric test scores | 50-70 minutes post-injection | We will evaluate correlation between standard uptake value ratio (SUVR) \[18F\]THK-5351 positron emission computed tomography and scores of neuropsychiatric test |
| Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of structural MRI | 50-70 minutes post-injection | We will evaluate correlation between standard uptake value ratio (SUVR) \[18F\]THK-5351 positron emission computed tomography and indices of structural MRI including cortical thickness, hippocampal atrophy. |
| Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of functional MRI | 50-70 minutes post-injection | We will evaluate correlation between standard uptake value ratio (SUVR) \[18F\]THK-5351 positron emission computed tomography and indices of functional MRI derived from diffusion tensor imaging and resting state functional MRI. |
| Correlation between standard uptake value ratios (SUVR) and distribution of [18F]THK-5351 positron emission computed tomography and amyloid positron emission computed tomography | 50-70 minutes post-injection | We will evaluate correlation between standard uptake value ratio (SUVR) and distribution of \[18F\]THK-5351 positron emission computed tomography and those of amyloid positron emission computed tomography |
Countries
South Korea
Outcome results
None listed