Psychometric Validation of Cognitive Endpoints

Multiple Sclerosis Clinical Trial

Official title:

Psychometric Validation of Cognitive Endpoints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335633
• Other study ID #: 691-11 PVCE
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: May 1, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Holy Name Hospital Multiple Sclerosis Center	Teaneck	New Jersey
United States	Kessler Foundation	West Orange	New Jersey
United States	Lauren S. Caruso	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Biogen

Country where clinical trial is conducted

United States,