Psychometric Validation of Cognitive Endpoints

NCT01335633 | Completed

• 1 other identifier: 691-11 PVCE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

MS; Neuropsychological tests

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with Multiple Sclerosis

You may qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Biogen: collaborator

Study Sites (4)

Holy Name Hospital Multiple Sclerosis Center

Teaneck, New Jersey, 07666, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Lauren S. Caruso

White Plains, New York, 10604, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John DeLuca, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Research

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (4)