Psychometric Validation of Cognitive Endpoints

May 1, 2012 updated by: John DeLuca, Kessler Foundation
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital Multiple Sclerosis Center
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo
      • White Plains, New York, United States, 10604
        • Lauren S. Caruso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with Multiple Sclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Biogen

Investigators

  • Principal Investigator: John DeLuca, Ph.D., Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 691-11 PVCE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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