Psychometric Validation of Cognitive Endpoints

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01335633
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 1.
• 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.
• Expected survival time of less than 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Holy Name Hospital Multiple Sclerosis Center; 🇺🇸 Teaneck, New Jersey, United States

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States

University at Buffalo; 🇺🇸 Buffalo, New York, United States

Lauren S. Caruso; 🇺🇸 White Plains, New York, United States