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Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination (PMPBB3/AV45)

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
F-18 PMPBB3
18F-florbetapir
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's disease, mild cognitive impairment, Neuroimages, 18F-PM-PBB3, 18F-flobetapir (AV-45), PET, MRI, Tau protein, Amyloid

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient with probable AD (Appendix I) Inclusion criteria

    1. Age ranges from 45~90 years
    2. Patients fulfill the criteria of probable AD (DSM IV and NINCDS-ADRDA)
    3. Mild cognitive impairment to moderate dementia (CDR: 0.5 to 2.0 or MMSE: 10-25)
    4. 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

  1. Age ranges from 45~90 years
  2. Patients fulfill the criteria of aMCI (The early aMCI and late aMCI were proposed by world ADNI)
  3. Amnestic mild cognitive impairment (CDR: 0.5 or MMSE: 26-30, with logical memory >=7)
  4. 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

  1. Age ranges from 45~90 years
  2. Patients fulfill the criteria of probable FTD
  3. Mild cognitive impairment to moderate dementia (CDR: 0.5 to 2.0 or MMSE: 10-25)
  4. 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

  1. Age ranges from 45~90 years
  2. Normal cognitive function (CDR: 0 or MMSE: 26-30)
  3. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception after the final study

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, 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)

Sites / Locations

  • Chang Gung Memorial Hospital,LinkouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

F-18-PMPBB3

18F-florbetapir

Arm Description

F-18-PMPBB3 imaging

18F-florbetapir (AV45) imaging

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2020
Last Updated
March 11, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04305210
Brief Title
Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination
Acronym
PMPBB3/AV45
Official Title
Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 23, 2021 (Anticipated)
Study Completion Date
January 23, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, mild cognitive impairment, Neuroimages, 18F-PM-PBB3, 18F-flobetapir (AV-45), PET, MRI, Tau protein, Amyloid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F-18-PMPBB3
Arm Type
Experimental
Arm Description
F-18-PMPBB3 imaging
Arm Title
18F-florbetapir
Arm Type
Experimental
Arm Description
18F-florbetapir (AV45) imaging
Intervention Type
Drug
Intervention Name(s)
F-18 PMPBB3
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-florbetapir
Intervention Description
18F-florbetapir
Primary Outcome Measure Information:
Title
Tau Distribution
Description
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.
Time Frame
1 YEAR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 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, 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Chang Huang, MD
Phone
03-3281200
Ext
8420
Email
cch0537@cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan
State/Province
Guishan Dist,
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Chang Huang, MD
Phone
03-3281200
Ext
8340
Email
cch0537@cgmh.org.tw

12. IPD Sharing Statement

Learn more about this trial

Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination

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