Alzheimer's DiseasePhase 2PMPBB3/AV45NCT04305210
Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination
A Phase 2 study testing F-18 PMPBB3 and 18F-florbetapir in people with Alzheimer's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Dementia is a common neurodegenerative syndrome in aged population. Alzheimer's disease (AD) is the most common disease. The main pathological findings in AD include senile plaques (SP) and neurofibrillary tangles (NFT). The b-amyloid is the main peptide in SP and tau protein is the main finding in NFT. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- F-18 PMPBB3 and 18F-florbetapir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2019to 23 Jan 2021
- Phase
- Phase 2
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with probable AD (Appendix I) Inclusion criteria
- Age ranges from 45~90 years
- Patients fulfill the criteria of probable AD (DSM IV and NINCDS-ADRDA)
- Mild cognitive impairment to moderate dementia (CDR: 0.5 to 2.0 or MMSE: 10-25)
- Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception after the final study
- Patient with amnestic MCI due to AD criteria (Appendix II: criteria proposed by world ADNI) Inclusion criteria
Show all 19Show fewer
- Age ranges from 45~90 years
- Patients fulfill the criteria of aMCI (The early aMCI and late aMCI were proposed by world ADNI)
- Amnestic mild cognitive impairment (CDR: 0.5 or MMSE: 26-30, with logical memory >=7)
- Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception after the final study
- Patients with probable FTD (Appendix III) 1, 2, 3 Inclusion criteria
- Age ranges from 45~90 years
- Patients fulfill the criteria of probable FTD
- Mild cognitive impairment to moderate dementia (CDR: 0.5 to 2.0 or MMSE: 10-25)
- Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception after the final study
- Healthy control Inclusion criteria
- Age ranges from 45~90 years
- Normal cognitive function (CDR: 0 or MMSE: 26-30)
- Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception after the final study
Who cannot join
- 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, acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases 3) Major psychiatric disorders, drug or alcohol abuse and major depression 4) Pregnant women or breast- feeding women 5) Subjects in whom MRI was contraindicated 6) History of severe allergic or anaphylactic reactions particularly to the tested drugs 7) History of positive test for human immunodeficiency virus (HIV) 8) Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital,Linkou
Taoyuan, Guishan Dist,, 333
Chin-Chang Huang, MD, 03-3281200 ext. 8340, cch0537@cgmh.org.tw
About this study
Dementia is a common neurodegenerative syndrome in aged population. Alzheimer's disease (AD) is the most common disease. The main pathological findings in AD include senile plaques (SP) and neurofibrillary tangles (NFT). The b-amyloid is the main peptide in SP and tau protein is the main finding in NFT. In addition, b-amyloid is considered as a disease biomarker, but the severity of AD is related with the tau protein.
Recently a new tracer 18F-PM-PBB3 has been introduced in tau PET images. In a prelimary study with the 18F-PM-PBB3, the tau PET scan provide a good tool to evaluate tau deposition pattern among healthy volunteers, and patients with mild and moderate dementia due to AD. In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation. We will follow up the clinical features for 2 years to understand the disease progression, disease conversion from aMCI to AD.
The study aims to investigate the deposition patterns of tau protein with 18F-PM-PBB3 and amyloid protein with 18F-flobetapir in patients with amnestic mild cognitive impairment due to AD, mild to moderate degree of dementia due to AD and healthy controls. The study will provide the information of these two proteins in different stages of dementia patients. The results may help the strategy in selection of anti-dementia drugs in the pharmaceutical company and industry and reduce the economic burden for the society. The study also can improve the understanding of Alzheimer's disease in academic research.
- Conditions
- Alzheimer's Disease
- Being tested
- F-18 PMPBB3, 18F-florbetapir
- Keywords
- Alzheimer's disease, mild cognitive impairment, Neuroimages, 18F-PM-PBB3, 18F-flobetapir (AV-45), PET, MRI, Tau protein, Amyloid
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 PMPBB3Drug
In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation.
18F-florbetapirDrug
18F-florbetapir
| Study group | Role | What they receive |
|---|---|---|
| F-18-PMPBB3 | Experimental | F-18-PMPBB3 imaging Receives: Drug: F-18 PMPBB3 |
| 18F-florbetapir | Experimental | 18F-florbetapir (AV45) imaging Receives: Drug: 18F-florbetapir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau Distribution
Tau Distribution Among healthy controls, amnestic mild cognitive impairment patients (aMCI), mild-moderate dementia due to AD and other dementia such as frontotemporal dementia. Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan and AV45 amyloid pet scan.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Dec 2019
- Primary completion23 Jan 2021 (estimated)
- Study completion23 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305210
- Sponsor's protocol ID
- 201802170A0
- Acronym
- PMPBB3/AV45
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination
- ClinicalTrials.gov ID
- NCT04305210
- Acronym / sponsor ID
- PMPBB3/AV45 / 201802170A0
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, mild cognitive impairment, Neuroimages, 18F-PM-PBB3, 18F-flobetapir (AV-45), PET, MRI, Tau protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 23 Jan 2021 (estimated)
- Study completion
- 23 Jan 2021 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia is a common neurodegenerative syndrome in aged population. Alzheimer's disease (AD) is the most common disease. The main pathological findings in AD include senile plaques (SP) and neurofibrillary tangles (NFT). The b-amyloid is the main peptide in SP and tau protein is the main finding in NFT. In addition, b-amyloid is considered as a disease biomarker, but the severity of AD is related with the tau protein.
Recently a new tracer 18F-PM-PBB3 has been introduced in tau PET images. In a prelimary study with the 18F-PM-PBB3, the tau PET scan provide a good tool to evaluate tau deposition pattern among healthy volunteers, and patients with mild and moderate dementia due to AD. In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation. We will follow up the clinical features for 2 years to understand the disease progression, disease conversion from aMCI to AD.
The study aims to investigate the deposition patterns of tau protein with 18F-PM-PBB3 and amyloid protein with 18F-flobetapir in patients with amnestic mild cognitive impairment due to AD, mild to moderate degree of dementia due to AD and healthy controls. The study will provide the information of these two proteins in different stages of dementia patients. The results may help the strategy in selection of anti-dementia drugs in the pharmaceutical company and industry and reduce the economic burden for the society. The study also can improve the understanding of Alzheimer's disease in academic research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-18-PMPBB3 | Experimental | Drug: F-18 PMPBB3F-18-PMPBB3 imaging |
| 18F-florbetapir | Experimental | Drug: 18F-florbetapir18F-florbetapir (AV45) imaging |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient with probable AD (Appendix I) Inclusion criteria
- Patient with amnestic MCI due to AD criteria (Appendix II: criteria proposed by world ADNI) Inclusion criteria
- Age ranges from 45~90 years
- Patients fulfill the criteria of aMCI (The early aMCI and late aMCI were proposed by world ADNI)
- Amnestic mild cognitive impairment (CDR: 0.5 or MMSE: 26-30, with logical memory >=7)
Key exclusion criteria (2 listed)
- 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, acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases 3) Major psychiatric disorders, drug or alcohol abuse and major depression 4) Pregnant women or breast- feeding women 5) Subjects in whom MRI was contraindicated 6) History of severe allergic or anaphylactic reactions particularly to the tested drugs 7) History of positive test for human immunodeficiency virus (HIV) 8) Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18 PMPBB3In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation. | Drug | F-18-PMPBB3 |
| 18F-florbetapir18F-florbetapir | Drug | 18F-florbetapir |
Primary outcome
Tau Distribution
Time frame: 1 YEAR
Tau Distribution Among healthy controls, amnestic mild cognitive impairment patients (aMCI), mild-moderate dementia due to AD and other dementia such as frontotemporal dementia. Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan and AV45 amyloid pet scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-18 PMPBB3 and 18F-florbetapir in people with Alzheimer's Disease, 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 19 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Chang Huang, MD (03-3281200 ext. 8420, cch0537@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tau Distribution (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2020.