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

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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