Psychometric Validation of Cognitive Endpoints

Kessler Foundation4 sites in 1 country60 target enrollmentMarch 2011

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Kessler Foundation
Enrollment: 60
Locations: 4
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

August 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kessler Foundation

Responsible Party

Principal Investigator

John DeLuca

Vice President of Research

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

•18 to 65 years old (inclusive).
•History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
•Physically able to see the testing materials and complete the tests
•Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.

Exclusion Criteria

•A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
•Untreated major depression or untreated anxiety disorder.
•History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
•History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
•A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
•History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day
•Active bacterial or viral infection.
•Use of marijuana within 2 months prior to Study Day 1or at any time during the study
•Alcohol consumption within 24 hours of either test session.
•Unable to comply with study requirements.