[18F]THK-5351 PET Study of Normal, Mild Cognitive Impairment, Alzheimer’s Disease and Other Neurodegenerative Disease
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0001785
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 180
General Subject Inclusion Criteria
1. Be = 40 and < 80 years of age at the Screening Visit.
2. 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.)
3. 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.
4. Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to [18F]THK-5351 PET scan ) or clinically acceptable to the investigator at screening.
5. 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.
6. If female, not be of childbearing potential as indicated by one of the following
7. 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.
8. Each subject must be willing to provided blood samples for genotyping ApoE.
- Cognitively Healthy Subjects
- Mild Cognitive Impairment subjects
- Alzheimer’s Disease subjects
- Subjects with other neurodegenerative disease
General Exclusion Criteria
-Based on the investigators’ judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
-The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
-If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] THK-5351 or its derivatives.
-The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
-The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
-The patient has contraindications to undergo PET or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
-The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
-The patient has been tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), HIV Antibody, or syphilis serum test at the screening visit.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in subjects with MCI, subjects with AD, subjects with odisease, subjects with MCI and cognitively healthy older individuals;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 Outcome Measures
Name Time Method Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 PET and neuropsychiatric test score;Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 PET and indices of structural MR;Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 PET and indices of functional MRI;Correlation between standard uptake value ratios (SUVR) and distribution of [18F]THK-5351 PET and amyloid PET