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

NCT04305210 | Unknown Phase 2

• 1 other identifier: 201802170A0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; mild cognitive impairment; Neuroimages; 18F-PM-PBB3; 18F-flobetapir (AV-45); PET; MRI; Tau protein; Amyloid

Outcome Measures

Primary Outcomes (1)

• 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.

  1 YEAR

Study Arms (2)

F-18-PMPBB3

EXPERIMENTAL

F-18-PMPBB3 imaging

Drug: F-18 PMPBB3

18F-florbetapir

EXPERIMENTAL

18F-florbetapir (AV45) imaging

Drug: 18F-florbetapir

Interventions

F-18 PMPBB3 DRUG

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.

F-18-PMPBB3

18F-florbetapir DRUG

18F-florbetapir

18F-florbetapir

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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
• 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

You may not qualify if:

• \) Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
• \) 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital,Linkou

Taoyuan District, Guishan Dist,, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Frontotemporal Dementia

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Chin-Chang Huang, MD

CONTACT

03-3281200; cch0537@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: December 1, 2019
• Primary Completion: January 23, 2021
• Study Completion: January 23, 2021
• Last Updated: March 12, 2020

Record last verified: 2019-03

Locations

TW (1)