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

NCT01767493 | Completed Phase 4 Results

• 1 other identifier: Florbetapir MS 01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis

Outcome Measures

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.

  1 year

Study Arms (1)

[18F]Florbetapir PET imaging

EXPERIMENTAL

\[18F\]Florbetapir and PET imaging

Drug: [18F]Florbetapir PET imaging

Interventions

[18F]Florbetapir PET imaging DRUG

\[18F\]Florbetapir and PET imaging

Also known as: Amyvid

[18F]Florbetapir PET imaging

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Biogen: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Stephanie Pizarro
• Organization: Invicro

spizarro@invicro.com

203-990-1613

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 14, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 30, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-06

Locations

US (1)