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

April 13, 2011
May 1, 2012
March 2011
August 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01335633 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychometric Validation of Cognitive Endpoints
Psychometric Validation of Cognitive Endpoints

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Individuals with Multiple Sclerosis

Multiple Sclerosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01335633
691-11 PVCE
No
John DeLuca, Kessler Foundation
Kessler Foundation
Biogen Idec
Principal Investigator: John DeLuca, Ph.D. Kessler Foundation
Kessler Foundation
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP