Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
1. oktober 2015 opdateret af: Biogen
Study to Establish Patient-Matched Population Norms for the MS-COG
The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United States (US), France, and Italy.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
467
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Thornton, Colorado, Forenede Stater, 80233
- Research Site
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Georgia
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Decatur, Georgia, Forenede Stater, 30033
- Research Site
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New York
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Latham, New York, Forenede Stater, 12110
- Research Site
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Ohio
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Akron, Ohio, Forenede Stater, 44320
- Research Site
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Bouches-du-Rhône
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Marseille Cedex 5, Bouches-du-Rhône, Frankrig, 13385
- Research Site
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Gironde
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Bordeaux, Gironde, Frankrig, 33076
- Research Site
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Milano, Italien, 20162
- Research Site
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Roma, Italien, 179
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 58 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This is a multinational, multicenter study that will be conducted in healthy adult volunteers to establish normative values for the MS-COG.
A total of 150 to 200 participants in each of the 3 countries will be enrolled.
The study sample will include healthy participants who are matched in age and level of education to the general MS patient population for the respective country and/or region.
Beskrivelse
Key Inclusion Criteria
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and Screening evaluations.
- Must be a native language speaker of the country where the study is being conducted.
Key Exclusion Criteria:
- Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (>30 min), cerebral ischemia, carotid artery disease, epilepsy, brain tumor, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, multiple sclerosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease.
- Medical illnesses/conditions that may affect brain function, such as untreated hypertension (blood pressure >140/100 mm Hg), cardiac disease, insulin-dependent diabetes mellitus, endocrine disorders, renal disease, glaucoma, and chronic obstructive pulmonary disease.
- Major psychiatric disturbance according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (US) Axis I criteria [American Psychiatric Association 2013] and the International Statistical Classification of Diseases and Related Health Problems, 10th revision Axis I criteria (Europe) [WHO 2010].
- History of developmental disorders.
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Participants with education less than bachelor's degree
Participants are further divided into three sub-groups based on their age group Group 1: Participants aged between 25 to 34 years Group 2: Participants aged between 35 to 44 years Group 3: Participants aged between 45 to 58 years
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Participants with bachelor's degree or equivalent
Participants are further divided into three sub-groups based on their age group Group 1: Participants aged between 25 to 34 years Group 2: Participants aged between 35 to 44 years Group 3: Participants aged between 45 to 58 years
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Selective Reminding Test (SRT) Score
Tidsramme: Day 1
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The SRT measures verbal learning and memory.
A participant is read a list of words and then asked to recall as many of the words as possible.
Six learning trials are conducted, followed by a delay trial approximately 20 to 40 minutes later.
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Day 1
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Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Tidsramme: Day 1
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The BVMT-R measures visual learning and memory.
The stimulus page is presented for 10 seconds, and the participant is then asked to reproduce the designs as accurately as possible and in the same location on the page.
Three learning trials are administered, followed by a delay trial approximately 20 to 40 minutes later.
Immediately following the delay trial a recognition trial is administered to see whether the participant recognizes the figures that were on the display.
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Day 1
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2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score
Tidsramme: Day 1
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The PASAT assesses auditory information processing speed.
A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it.
In the 2- and 3- second PASAT, numbers are presented at a rate of 1 every 2 or 3 seconds, respectively.
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Day 1
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Symbol Digit Modalities Test (SDMT) Score
Tidsramme: Day 1
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SDMT is a screening test for cognitive impairment.
Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key.
Scores range from 0 to 110 (best).
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Day 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2014
Primær færdiggørelse (Faktiske)
1. august 2015
Studieafslutning (Faktiske)
1. august 2015
Datoer for studieregistrering
Først indsendt
3. november 2014
Først indsendt, der opfyldte QC-kriterier
4. november 2014
Først opslået (Skøn)
5. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 999MS005
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .