Cognitively Normal, Mild Cognitive Impairment, Alzheimer Disease
Conditions
Keywords
[18F]PI-2620, tauopathy, positron emission computed tomography
Brief summary
The overall goal of this imaging trial is to evaluate crosssectional difference and longitudinal changes of \[18F\]PI-2620, a tau targeted positron emission computed tomography radioligand, in cognitively normal individuals, and subjects with mild cognitive impairment and Alzheimer's disease.
Interventions
DRUG[18F]PI-2620
Imaging for evaluating the accumulation of abnormal tau protein in the brain
Sponsors
Jae Seung Kim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 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 \< 85 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 \[18F\]PI-2620 positron emission computed tomography) or clinically acceptable to the investigator at screening. * 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. 2. Cognitively normal individuals 3. Subjects with Mild Cognitive Impairment 4. Subjects with Alzheimer 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 PI-2620 uptake measured by standard uptake value ratio (SUVR) | 60-90 minutes post injection | Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR) | 60-90 minutes post injection | Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease. |
| Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores | 60-90 minutes post-injectio | We will evaluate correlation between standard uptake value ratio (SUVR) \[18F\]PI-2620 positron emission computed tomography and scores of neuropsychiatric test |
| Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and indices of structural MRI | 60-90 minutes post injection | We will evaluate correlation between standard uptake value ratio (SUVR) \[18F\]PI-2620 positron emission computed tomography and indices of structural Magnetic Resonance Imaging including cortical volume, hippocampal atrophy. |
Countries
South Korea
Outcome results
None listed