ClinicalTrials.gg
CompletedNCT03625128Updated Oct 21, 2019

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

An Early Phase 1 interventional study of F-18 in Alzheimer's Disease, Cortical Basal Syndrome and Frontotemporal Dementia, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by Chang Gung Memorial Hospital · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2018, registered Jul 2018).
Phase
Early Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
20 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies in Alzheimer Disease by Chang Gung Memorial Hospital — 6 open to participants now, 6 under way, none of them phase 3. Alzheimer Disease · Chang Gung Memorial Hospital.

Enrollment
18th of 25
36 · median 67
Started
2018
with 1 other
Phase 1
3 of 27
1 open now
Registered
8th of 27
by date

Among the 27 studies in Alzheimer Disease by Chang Gung Memorial Hospital, this one is the 18th largest by enrollment of the 25 interventional ones that give a count, is one of 2 that started in 2018, is one of 3 in phase 1, and was the 8th registered.

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

6 of the 27 studies in Alzheimer Disease by Chang Gung Memorial Hospital are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.

This study: 20 Years to 90 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Alzheimer's Disease
  • Cortical Basal Syndrome
  • Frontotemporal Dementia
  • Progressive Supranuclear Palsy
  • Vascular Cognitive Impairment
04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written 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 for at least 1 year or, if they are of , must commit to use a barrier 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

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 (HIV).
  6. less than 1 year.
  7. Pregnant women, lactating or breast-feeding women.
  8. 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 drug or device within 30 days of screening
  13. Patients in whom MRI was 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    F-18 PMPBB3

    F-18 PMPBB3 imaging

    Drug: F-18

Interventions

  • DrugF-18

    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

06

What researchers measure

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.

    Time frame: YEAR ONE

Secondary outcomes

  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.

    Time frame: YEAR ONE

07

Study locations

1 site
  • Chang Gung Memorial Hospital,Linkou
    Taoyuan City, Guishan Dist 333, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Aug 2018, 7 months.

Of 73 non-industry phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's 7 months is below that.

Counting every sponsor, half of 233 studies reached it within 18 months; a quarter within 7 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2018
First posted
Aug 10, 2018
StartActual
Jan 2, 2018
Primary completionActual
Aug 3, 2018
CompletionActual
Dec 3, 2018
Last update
Oct 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03625128
Responsible party
Sponsor
First posted
Aug 10, 2018
Start date
Jan 2, 2018
Primary completion
Aug 3, 2018
Completion
Dec 3, 2018
Last update
Oct 21, 2019

Study contacts

Chin-Chang Huang
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Florzolotau F-18

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