Psychometric Validation of Cognitive Endpoints

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01335633

Enrollment

Registered

2011-04-14

Start date

2011-03-31

Completion date

2011-08-31

Last updated

2012-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

MS, Neuropsychological tests

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Countries

United States

Outcome results