Gilenya's Impact on Cognitive Function and Thalamic Volumes

NCT03243721 | Completed

• 1 other identifier: CCF 17-766
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This evaluation will be a one-year feasibility study to characterize the neuroprotective benefits of Gilenya and its effects on cognition and grey matter volumes. The study will enroll 15 patients with relapsing-remitting multiple sclerosis being treated with Gilenya and 5 healthy controls. Each participant will undergo a battery of neurometric testing at baseline, six months, and one year. In addition, patients will undergo high-field 7T MRI at the same time points.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; thalamus; high field MRI; cognition

Outcome Measures

Primary Outcomes (1)

• Thalamic volume to cognitive performance

  Spearman's correlation coefficient of change in thalamic volume and change in cognitive function from baseline to one year in RRMS patients treated with Gilenya.

  One year.

Secondary Outcomes (7)

• Thalamic volume to other MRI metrics

  Six months and one year.

• Thalamic nuclei to cognitive performance

  Six months and one year.

• Thalamic myelin density to cognitive performance

  Six months and one year.

• Thalamic axon density to cognitive performance

  Six months and one year.

• Changes in MRI metrics in Gilenya treated patients vs. controls

  Six months and one year.

Study Arms (2)

Gilenya treated MS patients

EXPERIMENTAL

Multiple sclerosis patients treated with Gilenya for at least six months. This group will receive diagnostic tests: 7T MRI and Neurocognitive testing.

Diagnostic Test: 7T MRI; Diagnostic Test: Neurocognitive testing

Healthy controls

EXPERIMENTAL

Subjects without multiple sclerosis or other diseases of the central nervous system. This group will receive diagnostic tests: 7T MRI and Neurocognitive testing.

Diagnostic Test: 7T MRI; Diagnostic Test: Neurocognitive testing

Interventions

7T MRI DIAGNOSTIC_TEST

A high field MRI that will take approximately one hour.

Gilenya treated MS patients; Healthy controls

Neurocognitive testing DIAGNOSTIC_TEST

A series of tests to assess memory, verbal skills, and visuospatial skills.

Gilenya treated MS patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• RRMS phenotype
• Treated with Gilenya for ≥6 months at the time of the baseline visit.
• Age 18-50 inclusive.
• EDSS 0-4.0
• Disease duration of 5-15 years.
• At least 12 years of education (high school diploma or general equivalency diploma).
• Physically capable of completing neurometric testing and MRI studies.
• Age 18-50 inclusive.
• At least 12 years of education (high school diploma or general equivalency diploma)
• Physically capable of completing neurometric testing and MRI studies.

You may not qualify if:

• Contraindication to MRI (e.g. metal implants)
• Current use of immunomodulatory or immunosuppressant medications other than Gilenya.
• Disease of the central nervous system other than MS (e.g. Alzheimer disease, stroke, epilepsy).
• Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months prior to enrollment will not be excluded.
• Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning.
• MS relapse within 90 days of study entry.
• Treatment with corticosteroids within 90 days of study entry.
• Current illicit substance use.
• History of alcohol or drug abuse.
• Contraindication to MRI (e.g. metal implants, claustrophobia).
• Disease of the central nervous system (e.g. MS, Alzheimer disease, stroke, epilepsy).
• Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months ago will not be excluded.
• Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning.
• Current illicit substance use.
• History of alcohol or drug abuse.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Devon S Conway, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be two groups running in parallel. One will be MS patients (15) and the other will be control patients (5). Both groups will receive the same interventions.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 9, 2017
• Study Start: October 20, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)