- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02283918
Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
1 oktober 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
467
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bouches-du-Rhône
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Marseille Cedex 5, Bouches-du-Rhône, Frankrike, 13385
- Research Site
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Gironde
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Bordeaux, Gironde, Frankrike, 33076
- Research Site
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Colorado
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Thornton, Colorado, Förenta staterna, 80233
- Research Site
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Georgia
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Decatur, Georgia, Förenta staterna, 30033
- Research Site
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New York
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Latham, New York, Förenta staterna, 12110
- Research Site
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Ohio
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Akron, Ohio, Förenta staterna, 44320
- Research Site
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Milano, Italien, 20162
- Research Site
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Roma, Italien, 179
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 58 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Selective Reminding Test (SRT) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2014
Primärt slutförande (Faktisk)
1 augusti 2015
Avslutad studie (Faktisk)
1 augusti 2015
Studieregistreringsdatum
Först inskickad
3 november 2014
Först inskickad som uppfyllde QC-kriterierna
4 november 2014
Första postat (Uppskatta)
5 november 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 oktober 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 oktober 2015
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 999MS005
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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