Psychometric Validation of Cognitive Endpoints

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
John DeLuca, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01335633
First received: April 13, 2011
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychometric Validation of Cognitive Endpoints

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Enrollment: 60
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals with Multiple Sclerosis

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335633

Locations
United States, New Jersey
Holy Name Hospital Multiple Sclerosis Center
Teaneck, New Jersey, United States, 07666
Kessler Foundation
West Orange, New Jersey, United States, 07052
United States, New York
University at Buffalo
Buffalo, New York, United States, 14203
Lauren S. Caruso
White Plains, New York, United States, 10604
Sponsors and Collaborators
Kessler Foundation
Biogen Idec
Investigators
Principal Investigator: John DeLuca, Ph.D. Kessler Foundation
  More Information

No publications provided

Responsible Party: John DeLuca, Vice President of Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01335633     History of Changes
Other Study ID Numbers: 691-11 PVCE
Study First Received: April 13, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
MS
Neuropsychological tests

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014