Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis
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.
Interventions
DRUG[18F]Florbetapir PET imaging
\[18F\]Florbetapir and PET imaging
Sponsors
Biogen
Institute for Neurodegenerative Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Lesions Detected by [18F]Florbetapir PET | 1 year | This study demonstrates the feasibility of\[18F\]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| [18F]Florbetapir PET Imaging \[18F\]Florbetapir and PET imaging | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen failures | 3 |
Baseline characteristics
| Characteristic | [18F]Florbetapir PET Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Total Number of Lesions Detected by [18F]Florbetapir PET
This study demonstrates the feasibility of\[18F\]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| [18F]Florbetapir PET Imaging | Total Number of Lesions Detected by [18F]Florbetapir PET | 194 Lesions |