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Alzheimer's DiseaseEarly Phase 1NCT03625128

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

A Early Phase 1 study testing F-18 in people with Alzheimer's Disease and Cortical Basal Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
What is being tested?
F-18
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTaiwan
Study dates
2 Jan 2018to 3 Dec 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan City, Guishan Dist, 333

Other trials in Taiwan

About this study

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

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.

Being tested
F-18
Medical subject headings
Alzheimer Disease, Frontotemporal Dementia, Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • F-18Drug

    Also called F-18 PMPBB3

    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).

Study groups in NCT03625128
Study groupRoleWhat they receive
F-18 PMPBB3ExperimentalF-18 PMPBB3 imaging
Receives: Drug: F-18

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: YEAR ONE

Secondary outcomes (1)

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

    PET data will be acquired using SIMENS PET/CT or PET/MRI scanner with an axial field of view of 15.7cm. For PET/CT protocol, a 50-min dynamic brain PET scan (6x10s, 4x60s, 5x180s, 6x300s) will be started simultaneously with the injection of 10mCi of 18F-PM-PBB3 after a low-dose CT scan for patient positioning and attenuation correction.

    Measured: YEAR ONE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start2 Jan 2018
  3. Primary completion3 Aug 2018
  4. Study completion3 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625128
Sponsor's protocol ID
201700982A0
Status last verified
Aug 2018
First submitted
12 Jul 2018
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38563872

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing F-18 in people with Alzheimer's Disease and Cortical Basal Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measures are to evaluate the dosimetry of novel radiotracer 18F-PM-PBB3 in human. (time frame: YEAR ONE). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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