Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305210
Recruitment Status : Unknown
Verified March 2019 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: F-18 PMPBB3 Drug: 18F-florbetapir Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : January 23, 2021
Estimated Study Completion Date : January 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F-18-PMPBB3
F-18-PMPBB3 imaging
Drug: F-18 PMPBB3
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.

Experimental: 18F-florbetapir
18F-florbetapir (AV45) imaging
Drug: 18F-florbetapir
18F-florbetapir




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305210


Contacts
Layout table for location contacts
Contact: Chin-Chang Huang, MD 03-3281200 ext 8420 cch0537@cgmh.org.tw

Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital,Linkou Recruiting
Taoyuan, Guishan Dist,, Taiwan, 333
Contact: Chin-Chang Huang, MD    03-3281200 ext 8340    cch0537@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04305210    
Other Study ID Numbers: 201802170A0
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Alzheimer's disease
mild cognitive impairment
Neuroimages
18F-PM-PBB3
18F-flobetapir (AV-45)
PET
MRI
Tau protein
Amyloid
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders