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

NCT ID: NCT01767493

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[18F]Florbetapir PET imaging

\[18F\]Florbetapir and PET imaging

Group Type: EXPERIMENTAL

[18F]Florbetapir PET imaging

Intervention Type: DRUG

\[18F\]Florbetapir and PET imaging

Interventions

[18F]Florbetapir PET imaging

\[18F\]Florbetapir and PET imaging

Intervention Type: DRUG

Other Intervention Names

Amyvid

Eligibility Criteria

Inclusion Criteria

• No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danna Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Countries

United States

Related Links

http://www.indd.org

Institute for Neurodegenerative Disorders

Other Identifiers

Florbetapir MS 01

Identifier Type: -

Identifier Source: org_study_id