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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02016560
First received: December 16, 2013
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir F 18
Drug: 18F-AV-1451
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Cross-sectional 18F-AV-1451 Imaging Results [ Time Frame: 80-130 minutes post injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake (SUVR) over time.


Secondary Outcome Measures:
  • 18F-AV-1451 imaging in healthy individuals [ Time Frame: 80-130 minutes post-injection ] [ Designated as safety issue: No ]
    Describe the tau SUVR distribution across age groups among cognitively healthy subjects.


Estimated Enrollment: 230
Study Start Date: December 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807
Experimental: 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.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807
Experimental: 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.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016560

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

  Show 27 Study Locations
Sponsors and Collaborators
Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02016560     History of Changes
Other Study ID Numbers: 18F-AV-1451-A05
Study First Received: December 16, 2013
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014