CClinicalTrials.gg
CompletedNCT01767493Updated Aug 30, 2021Results posted

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

A Phase 4 interventional study of [18F]Florbetapir PET imaging in Multiple Sclerosis, sponsored by Institute for Neurodegenerative Disorders. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-30.

Sponsored by Institute for Neurodegenerative Disorders · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Institute for Neurodegenerative Disorders is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    [18F]Florbetapir PET imaging

    \[18F\]Florbetapir and PET imaging

    Drug: [18F]Florbetapir PET imaging

Interventions

  • Drug[18F]Florbetapir PET imaging

    \[18F\]Florbetapir and PET imaging

    Also known as: Amyvid

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Aug 27, 2021

Participant flow

Participant flow — Overall Study
Milestone[18F]Florbetapir Imaging
Started19
Completed16
Not completed3
Withdrew: Screen failures3

Outcome measures

PrimaryTotal 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
Reported as:
Number · Lesions
Total Number of Lesions Detected by [18F]Florbetapir PET
Lesions[18F]Florbetapir PET Imaging
Total Number of Lesions Detected by [18F]Florbetapir PET194

Adverse events

Collected over Adverse event data was collected for 1 year.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
[18F]Florbetapir PET Imaging0/19 (0%)0/19 (0%)2/19 (10.5%)
Most frequent other events
Most frequent other events
Event[18F]Florbetapir PET Imaging
Wrist PainInjury, poisoning and procedural complications1/19
Chest Wall CongestionRespiratory, thoracic and mediastinal disorders1/19
Gastroesophageal RefluxGastrointestinal disorders1/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)[18F]Florbetapir PET Imaging
<=18 years0
Between 18 and 65 years19
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)[18F]Florbetapir PET Imaging
Female12
Male7
08

Study locations

1 site
  • Institute for Neurodegenerative Disorders
    New Haven, Connecticut 06510, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01767493
Lead sponsor
Institute for Neurodegenerative Disorders
Collaborators
Biogen
Responsible party
Sponsor
First posted
Jan 14, 2013
Start date
Nov 2012
Primary completion
Nov 2013
Completion
Nov 2013
Results posted
Aug 27, 2021
Last update
Aug 30, 2021

Study contacts

Danna Jennings, MD
principal investigator · Institute for Neurodegenerative Disorders

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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