Clinical trial NCT01767493: Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2013-01-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Total Number of Lesions Detected by [18F]Florbetapir PET
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: