Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects

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: NCT02016560
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date October 25, 2018
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Cross-sectional 18F-AV-1451 Imaging Results [ Time Frame: 80-130 minutes post injection ]
    Compare standard uptake value ratio (SUVR) in subjects with AD to subjects with MCI and cognitively healthy older individuals.
  • Change in tau deposition over time [ Time Frame: 18 months ]
    Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake (SUVR) over time.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02016560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
18F-AV-1451 imaging in healthy individuals [ Time Frame: 80-130 minutes post-injection ]
Describe the tau SUVR distribution across age groups among cognitively healthy subjects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects
Official Title  ICMJE An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease
Brief Summary This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
All subjects in both the exploratory and confirmatory phases of the study, receive both AV-1451 and florbetapir scans, regardless of subgroup assignment.
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: florbetapir F 18
    Other Names:
    • Amyvid
    • 18F-AV-45
  • Drug: 18F-AV-1451
    Other Name: T807
Study Arms  ICMJE
  • Experimental: Exploratory Cognitively Healthy Subjects
    Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Cross-sectional and longitudinal subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline. Longitudinal subjects only will receive an IV injection, 370 MBq (10 mCi) of 18F-AV-1451 at 9 and 18 months.
    Interventions:
    • Drug: florbetapir F 18
    • Drug: 18F-AV-1451
  • Experimental: Exploratory MCI Subjects
    Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
    Interventions:
    • Drug: florbetapir F 18
    • Drug: 18F-AV-1451
  • Experimental: Exploratory AD Subjects
    Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
    Interventions:
    • Drug: florbetapir F 18
    • Drug: 18F-AV-1451
  • Experimental: Confirmatory Subjects
    Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and 18F-AV-1451 at baseline.
    Interventions:
    • Drug: florbetapir F 18
    • Drug: 18F-AV-1451
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
383
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
230
Actual Study Completion Date  ICMJE July 28, 2017
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Exploratory Cognitively Healthy Subjects

  • ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
  • Mini-mental state examination (MMSE) ≥ 29
  • No significant history of cognitive impairment

Exploratory MCI Subjects

  • ≥ 50 years of age
  • MMSE ≥ 24
  • Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living

Exploratory AD Subjects

  • ≥ 50 years of age
  • MMSE > 10
  • Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living

Confirmatory Subjects

  • ≥ 50 years of age
  • MMSE ≥ 20 and ≤ 27
  • Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
  • Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

  • Current clinically significant psychiatric disease
  • Evidence of structural brain abnormalities
  • History of moderate or severe traumatic brain injury
  • Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
  • Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • History of alcohol or substance abuse or dependence
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016560
Other Study ID Numbers  ICMJE 18F-AV-1451-A05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avid Radiopharmaceuticals
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP