Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Institute for Neurodegenerative Disorders
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT01767493
First received: December 13, 2012
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.


Condition Intervention
Multiple Sclerosis
Drug: [18F]Florbetapir and PET imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Feasibility of [18F]Florbetapir PET [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the feasibility of [18F]Florbetapir PET as a biomarker for assessment of demyelination in MS subjects compared to healthy volunteers.


Secondary Outcome Measures:
  • Comparison of PET with MRI for demyelination in Multiple Sclerosis subjects [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]Florbetapir and PET imaging
Subjects will have a baseline scan and second scan within 1 month following the baseline PET scan
Drug: [18F]Florbetapir and PET imaging
Subjects will have a baseline scan and second scan within 1 month following the baseline PET scan
Other Name: Amyvid

Detailed Description:

The underlying goal of this study is to assess the feasibility of [18F]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility criteria (for all subjects):

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
  • Willingness to comply with study procedures
  • Willingness to provide written informed consent
  • Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent
  • Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed
  • For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of [18F]Florbetapir PET injection

Inclusion Criteria (Healthy Volunteers):

  • No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.

Inclusion Criteria (MS Subjects):

  • Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria
  • Have at least 10 demyelinating lesion on brain MRI with the following characteristics:
  • Hypointense on T2 weighted images with FLAIR

Exclusion Criteria (for all subjects):

  • The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.
  • Women who are pregnant or actively breastfeeding
  • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
  • The subject has participated in another clinical study within the previous 30 days
  • Renal impairment with a creatine clearance <80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)
  • The subject is scheduled to have a major surgery or procedure during the time of the study.
  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: NCT01767493

Contacts
Contact: Barbara Fussell, RN 203-401-4300

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Danna Jennings, MD         
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Biogen Idec
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
  More Information

Additional Information:
No publications provided

Responsible Party: Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT01767493     History of Changes
Other Study ID Numbers: Florbetapir MS 01
Study First Received: December 13, 2012
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Neurodegenerative Disorders:
Multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014