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

Institute for Neurodegenerative Disorders

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: [18F]Florbetapir PET imaging

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01767493

Florbetapir MS 01

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.