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

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ClinicalTrials.gov Identifier: NCT01767493
Recruitment Status : Unknown
Verified June 2013 by Danna Jennings, MD, Institute for Neurodegenerative Disorders.
Recruitment status was:  Recruiting
First Posted : January 14, 2013
Last Update Posted : June 6, 2013
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders

Brief Summary:
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 or disease Intervention/treatment
Multiple Sclerosis Drug: [18F]Florbetapir and PET imaging

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2012
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Feasibility of [18F]Florbetapir PET [ Time Frame: 2 years ]
    Evaluate the feasibility of [18F]Florbetapir PET as a biomarker for assessment of demyelination in MS subjects compared to healthy volunteers.


Secondary Outcome Measures :
  1. Comparison of PET with MRI for demyelination in Multiple Sclerosis subjects [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders

Additional Information:
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
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Danna Jennings, MD, Institute for Neurodegenerative Disorders:
Multiple sclerosis

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