Measuring Active Microglia in Progressive Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 24 January 2022
• Main ID: NCT02207075
• Date of registration: 30/07/2014
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Measuring Active Microglia in Progressive Multiple Sclerosis
• Scientific title: Measuring Active Microglia in Progressive Multiple Sclerosis
• Date of first enrolment: July 2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02207075
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Susan Gauthier, DO
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects age 18-80

- Secondary progressive MS subjects either untreated or on consistent treatment for
six-months prior to enrollment

- Norman Controls

Exclusion Criteria:

- Subjects pregnant or woman of child-bearing age not utilizing effective birth control

- Primary progressive MS subjects

- Relapsing remitting MS subjects

- Unstable SPMS subject for which treatment change within the 24 months is likely

Age-Healthy controls will be excluded if have any of the following medical conditions:

- Any central nervous system disorder

- Any systemic auto-immune disorder

- Pregnant or woman of child-bearing age not utilizing effective birth control

Subjects will be withdrawn from the study if treatment is changed during the 24-month study



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Progressive Multiple Sclerosis

Intervention(s)

Drug: [C11]PK-1195 PET scan

Primary Outcome(s)

Measure the level of baseline and change of whole brain uptake of [11C]PK-11195 at 6, 12 and 24 months in SPMS subjects. [Time Frame: 24 months]

Secondary Outcome(s)

To correlate the change in T2-hyperintense lesion volume at 6,12 and 24 months of with whole brain uptake of [11C]PK-11195 on PET (at the 6,12 and 24 months) in SPMS subjects. [Time Frame: 24 months]

To correlate the change in whole brain PET uptake of [11C]PK-11195 (at the 6,12 and 24 months) and level in disability, as measured by a change in EDSS at 6, 12, and 24 months in SPMS subjects. [Time Frame: 24 months]

To correlate the change of conventional MRI measures of neuronal integrity (Gray Matter Fraction, White Matter Fraction, whole brain volume, T1-hypointense lesion volume) at 6,12 and 24 months with whole brain PET uptake of [11C]PK-11195 (at the 6,12 and [Time Frame: 24 months]

Secondary ID(s)

1309014365

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genzyme, a Sanofi Company