Psychometric Validation of Cognitive Endpoints
Completed
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01335633
- Run by
- Kessler Foundation
- People needed
- 60
- Starts
- 2011-03-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2012-05-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Holy Name Hospital Multiple Sclerosis Center — Teaneck, New Jersey, United States
- Kessler Foundation — West Orange, New Jersey, United States
- University at Buffalo — Buffalo, New York, United States
- Lauren S. Caruso — White Plains, New York, United States
Full record on ClinicalTrials.gov
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