Psychometric Validation of Cognitive Endpoints
This study has been completed.
Sponsor:
Kessler Foundation
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
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Kessler Foundation:
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
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 May 16, 2013