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

NCT03625128 | Completed Early Phase 1

• 1 other identifier: 201700982A0
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Cortical Basal Syndrome; Frontotemporal Dementia; Progressive Supranuclear Palsy; Vascular Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures are to evaluate the dosimetry of novel radiotracer 18F-PM-PBB3 in human.

  Time-integrated activity in each organ will be calculated by trapezoidal integration of the first 45 min of the organ's time-activity curve, followed by a single-exponential fit to the remaining data points (based on the 4 whole-body images) extrapolate to infinity, all base on non-decay-corrected data.Residence times will be obtained by dividing the time-integrated activity by the injected amount of activity.

  YEAR ONE

Secondary Outcomes (1)

• Optimal scanning time for brain imaging using 18F-PM-PBB3 .

  YEAR ONE

Study Arms (1)

F-18 PMPBB3

EXPERIMENTAL

F-18 PMPBB3 imaging

Drug: F-18

Interventions

F-18 DRUG

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).

Also known as: F-18 PMPBB3

F-18 PMPBB3

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• 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.
• 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.
• Male subjects must not donate sperm for the study duration.
• Willing and able to cooperate with study procedures

You may not qualify if:

• Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
• 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.
• Current or prior history of major psychiatric disorders, epilepsy and major depression.
• History of severe allergic or anaphylactic reactions particularly to the tested drugs.
• History of positive test for human immunodeficiency virus (HIV).
• Life expectancy less than 1 year.
• Pregnant women, lactating or breast-feeding women.
• Clinically significant abnormal laboratory values and/or clinically significant or unstable medical or psychiatric illness.
• Substance abuse or alcoholism for at least 3 months.
• Cognitive impairment resulting from trauma brain injury.
• 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.
• Subject has received an investigational drug or device within 30 days of screening
• Patients in whom MRI was contraindicated and with history of claustrophobia in MRI
• 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.
• Subjects having high risks for the study according to the PI discretion.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital,Linkou

Taoyuan, Guishan Dist, 333, Taiwan

Location

Related Publications (1)

• Lin KJ, Huang SY, Huang KL, Huang CC, Hsiao IT. Human biodistribution and radiation dosimetry for the tau tracer [18F]Florzolotau in healthy subjects. EJNMMI Radiopharm Chem. 2024 Apr 2;9(1):27. doi: 10.1186/s41181-024-00259-x.

  PMID: 38563872 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Basal Ganglia Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chin-Chang Huang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 10, 2018
• Study Start: January 2, 2018
• Primary Completion: August 3, 2018
• Study Completion: December 3, 2018
• Last Updated: October 21, 2019

Record last verified: 2018-08

Locations

TW (1)