search
Back to results

Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Flortaucipir F18
Brain PET scan
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
  • Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

Exclusion Criteria:

  • lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
  • history of electroconvulsive therapy
  • MRI contraindicated
  • claustrophobic or, otherwise, unable to tolerate the imaging procedure
  • current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
  • history of additional risk factors for Torsades de Pointes
  • current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
  • history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
  • current drug or alcohol abuse/dependence
  • history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
  • females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Alzheimer's disease (AD)

    Mild cognitive impairment (MCI)

    Subjective memory complainers (SMC)

    Cognitively normal (CN)

    Arm Description

    Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months

    Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months

    Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months

    Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months

    Outcomes

    Primary Outcome Measures

    Flortaucipir PET Imaging (Quantitative)
    Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
    Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
    Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2020
    Last Updated
    September 3, 2020
    Sponsor
    Avid Radiopharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04468347
    Brief Title
    Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
    Official Title
    18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (Actual)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Avid Radiopharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.
    Detailed Description
    The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alzheimer's disease (AD)
    Arm Type
    Experimental
    Arm Description
    Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
    Arm Title
    Mild cognitive impairment (MCI)
    Arm Type
    Experimental
    Arm Description
    Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
    Arm Title
    Subjective memory complainers (SMC)
    Arm Type
    Experimental
    Arm Description
    Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
    Arm Title
    Cognitively normal (CN)
    Arm Type
    Experimental
    Arm Description
    Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Flortaucipir F18
    Other Intervention Name(s)
    18F-AV-1451, [F-18]T807, LY3191748, Tauvid
    Intervention Description
    IV injection, 240 megabecquerel (MBq) (6.5 mCi)
    Intervention Type
    Procedure
    Intervention Name(s)
    Brain PET scan
    Intervention Description
    positron emission tomography (PET) scan of the brain
    Primary Outcome Measure Information:
    Title
    Flortaucipir PET Imaging (Quantitative)
    Description
    Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
    Time Frame
    baseline scan
    Title
    Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
    Description
    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
    Time Frame
    baseline scan
    Title
    Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
    Description
    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
    Time Frame
    baseline scan

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms Exclusion Criteria: lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder history of electroconvulsive therapy MRI contraindicated claustrophobic or, otherwise, unable to tolerate the imaging procedure current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram history of additional risk factors for Torsades de Pointes current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation history of cancer (other than skin or in situ prostate cancer) within the previous 5 years current drug or alcohol abuse/dependence history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chief Medical Officer
    Organizational Affiliation
    Avid Radiopharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://aibl.csiro.au/
    Description
    Link to the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) website

    Learn more about this trial

    Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

    We'll reach out to this number within 24 hrs