Brief Title
18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
Official Title
Phase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
Brief Summary
This is an open-label study to evaluate the performance of a novel tau imaging ligand in up
to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV). Subjects will be recruited from
the patient population and healthy volunteers of Taiwan residents. This study protocol
requires each subject to complete the following components: screening evaluation, brain MRI
and 18F-PM-PBB3 PET imaging up to two sessions. The screening procedures will include
neuropsychological assessments, vital signs, ECG, physical examinations and laboratory tests.
In addition, 18F-AV-45 PET imaging result will be as a part of inclusion criteria to confirm
presence of amyloid deposition in patients with clinically diagnosed probable AD or absence
of amyloid deposition in FTD, VCI and HV subjects. Furthermore, 18F-AV-133 PET imaging data
will also be as a part of inclusion criteria to confirm the diagnosis of PSP and CBS. All
subjects will complete clinical assessments and clinical safety tests to ensure the subject
is medically stable to complete the study protocol. The screening procedures will occur
within 30 days prior to 18F-PMPBB3 PET imaging.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
The primary outcome measures are to evaluate the dosimetry of novel radiotracer 18F-PM-PBB3 in human.
Secondary Outcome
Optimal scanning time for brain imaging using 18F-PM-PBB3 .
Condition
Alzheimer's Disease
Intervention
F-18
Study Arms / Comparison Groups
F-18 PMPBB3
Description: F-18 PMPBB3 imaging
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
January 2, 2018
Completion Date
December 3, 2018
Primary Completion Date
August 3, 2018
Eligibility Criteria
Inclusion Criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Female subjects must be documented by medical records or physician's note to be either
surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal
ligation) or post-menopausal for at least 1 year or, if they are of child-bearing
potential, must commit to use a barrier contraception method for the duration of the
study.
3. Male subjects and their partners of childbearing potential must commit to the use of
two methods of contraception, one of which is a barrier method for male subjects for
the study duration.
4. Male subjects must not donate sperm for the study duration.
5. Willing and able to cooperate with study procedures
Exclusion Criteria:
1. Implantation of metal devices including cardiac pacemaker, intravascular metal
devices.
2. Major systemic diseases including coronary arterial disease, heart failure, uremia,
hepatic failure, prominent strokes (except for patients with VCI), acute myocardial
infarction, poorly controlled diabetes, previous head injury, intracranial operation,
hypoxia, sepsis or severe infectious diseases.
3. Current or prior history of major psychiatric disorders, epilepsy and major
depression.
4. History of severe allergic or anaphylactic reactions particularly to the tested drugs.
5. History of positive test for human immunodeficiency virus (HIV).
6. Life expectancy less than 1 year.
7. Pregnant women, lactating or breast-feeding women.
8. Clinically significant abnormal laboratory values and/or clinically significant or
unstable medical or psychiatric illness.
9. Substance abuse or alcoholism for at least 3 months.
10. Cognitive impairment resulting from trauma brain injury.
11. Prior participation in other research protocols or clinical care in the last year in
addition to the radiation exposure expected from participation in this clinical study,
such that radiation exposure exceeds the effective dose of 50 mSv.
12. Subject has received an investigational drug or device within 30 days of screening
13. Patients in whom MRI was contraindicated and with history of claustrophobia in MRI
14. General MRI, and / or PET exclusion criteria. MRI exclusion criteria include: Findings
of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct
>1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3
with at least one confluent hyperintense lesion on the FLAIR sequence that is ≥20 mm
in any dimension, except for patients with VCI), infectious disease, space-occupying
lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS
disease.
15. Severe language impairment precluding cognitive assessments, defined as a score of 3
points in the language score of the National Institute of Health Stroke Scale.
16. Subjects having high risks for the study according to the PI discretion.
Gender
All
Ages
20 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Chin-Chang Huang, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT03625128
Organization ID
201700982A0
Responsible Party
Sponsor
Study Sponsor
Chang Gung Memorial Hospital
Study Sponsor
Chin-Chang Huang, Principal Investigator, Chang Gung Memorial Hospital
Verification Date
August 2018