Psychometric Validation of Cognitive Endpoints

NCT ID: NCT01335633

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

John DeLuca

Vice President of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John DeLuca, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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

Countries

United States

Other Identifiers

691-11 PVCE

Identifier Type: -

Identifier Source: org_study_id