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OpenTrials
Completed

NCT Number: NCT01335633

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Holy Name Hospital Multiple Sclerosis Center, Teaneck, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Biogen

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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