18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03625128
• Date of registration: 12/07/2018
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
• Scientific title: Phase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
• Date of first enrolment: January 2, 2018
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03625128
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

Taiwan

Contacts

• Name: Chin-Chang Huang
• Affiliation: Chang Gung Memorial Hospital

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Vascular Cognitive Impairment

Alzheimer's Disease

Cortical Basal Syndrome

Progressive Supranuclear Palsy

Frontotemporal Dementia

Intervention(s)

Drug: F-18

Primary Outcome(s)

The primary outcome measures are to evaluate the dosimetry of novel radiotracer 18F-PM-PBB3 in human. [Time Frame: YEAR ONE]

Secondary Outcome(s)

Optimal scanning time for brain imaging using 18F-PM-PBB3 . [Time Frame: YEAR ONE]

Secondary ID(s)

201700982A0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors