- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01888185
Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)
2 januari 2020 uppdaterad av: Xuemei Huang, MD, PhD, Milton S. Hershey Medical Center
Multimodal MRI Markers of Nigrostriatal Pathology in Parkinson's Disease
This study is designed to determine if magnetic resonance imaging (MRI) measures can be used to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing between PD and parkinsonisms [conditions that are PD look-a-like diseases such as progressive supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with changes in certain proteins in body fluids that are related to iron (Fe).
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
The lack of in vivo biomarker(s) reflecting Parkinson's disease (PD)-related cell loss and associated pathoetiological/physiological processes in nigrostriatal structures has hindered discovery research and limited the ability to evaluate disease-modifying therapies.
Recent research has generated excitement for using DTI and R2* MRI measures as biomarker(s) for PD-related pathology in nigrostriatal pathways, but they fall short by the lack of understanding of their clinical implications and biological/pathological underpinnings.
Working closely with the National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Biomarkers Program (PDBP), the proposed work will investigate multimodal MRI techniques in combination with fluid-based iron (Fe) protein profiles to serve as in vivo markers for PD-related nigrostriatal pathology that can be used as biomarkers for diagnosing PD, following its progression, and gaining mechanistic understanding of PD pathoetiology and pathophysiology.
Studietyp
Observationell
Inskrivning (Faktisk)
290
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Milton S. Hershey Medical Center and College of Medicine
-
-
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
21 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Clinical patients and community volunteers
Beskrivning
Inclusion Criteria:
PD Subjects:
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- MMSE score of 15 or greater unless a legal representative is present.
- Idiopathic PD according to published criteria.
- History of adequate response to dopaminergic therapy.
- History of asymmetrical symptom onset
MSA Subjects:
- Older than 30 yrs.
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- MMSE score of 15 or greater unless a legal representative is present.
- MSA according to published criteria.
- History of autonomic & urinary dysfunction and/or severe cerebellar ataxia.
PSP Subjects:
- Older than 40 yrs.
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- PSP according to published criteria.
- Vertical gaze palsy and/or slow vertical gaze/postural instability during first year of diagnosis.
- MMSE score of 15 or greater unless a legal representative is present
Controls:
- Older than 21 yrs.
- Able and willing to sign the consent form.
- MMSE greater than 24.
Exclusion Criteria:
PD Subjects:
- Unable or does not have a legal representative/unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-PD-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
MSA Subjects:
- Unable or does not have a legal representative /unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-MSA-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
PSP Subjects:
- Unable or does not have a legal representative /unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-PSP-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
Controls:
- Unable/unwilling to provide consent.
- Evidence of severe memory impairment or signs of dementia (MMSE < 24).
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable medical conditions.
- Use of anticoagulant medications.
- Signs of dementia.
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 |
---|
Parkinson's Disease (PD)
Patients with a clinical diagnosis of PD (in various stages)
|
Progressive supranuclear palsy (PSP)
Patients with a clinical diagnosis of PSP (in various stages)
|
Multiple system atrophy (MSA)
Patients with a clinical diagnosis of MSA (in various stages)
|
Controls
Age and gender-matched adults free from neurological disease
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Differential roles of fractional anisotropy (FA) and R2* in PD detection and progression
Tidsram: Change in roles of FA and R2* assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.
|
Substantia Nigra (SN) FA and R2* values in PD subjects will be compared with control subjects and correlated with clinical and behavioral measures.
|
Change in roles of FA and R2* assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Nigrostriatal diffusion tensor imaging (DTI) and R2* differentiate PD from parkinsonian syndromes
Tidsram: Assessed at baseline visit.
|
DTI and R2* measures in both SN and striatal structures in PD, PSP, MSA and control subjects will be compared to assess sensitivity and specificity of individual and combined MRI measures in diagnosing PD.
|
Assessed at baseline visit.
|
Iron(Fe)-related proteins in body fluids as biomarkers of PD
Tidsram: Change assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.
|
The protein profile in blood, urine, and cerebral spinal fluid (CSF), and their relationships to clinical and MRI measure will be interrogated with the focus being on Fe-related proteins such as hepcidin, ferritin, and transferrin.
|
Change assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.
|
MRI and postmortem pathological correlation
Tidsram: From baseline until date of death from any cause within 5 years for patient participants who succumb to their disease
|
Postmortem brain analysis on patients who succumb to their disease during the study will be performed in order to inform the relationship of the biomarkers to clinical diagnosis (PD, PSP, MSA) and clinical milestones as well as to inform the pathological underpinnings of the R2* and DTI measures.
In addition to standard postmortem diagnostic tests (alpha-synuclein, beta-amyloid, tau, and ubiquitin), total Fe staining, ferritin, hepcidin, tyrosine hydroxylase positive neurons, myelin and glial derived growth factors (glial cell markers) will be assessed in nigrostriatal structures in order to correlate these levels with MRI measures.
|
From baseline until date of death from any cause within 5 years for patient participants who succumb to their disease
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 december 2012
Primärt slutförande (Faktisk)
1 december 2019
Avslutad studie (Faktisk)
31 december 2019
Studieregistreringsdatum
Först inskickad
17 januari 2013
Först inskickad som uppfyllde QC-kriterierna
25 juni 2013
Första postat (Uppskatta)
27 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Ögonsjukdomar
- Neurologiska manifestationer
- Basala ganglia sjukdomar
- Rörelsestörningar
- Synukleinopatier
- Neurodegenerativa sjukdomar
- Tauopatier
- Kranial nervsjukdomar
- Autonoma nervsystemets sjukdomar
- Okulära motilitetsstörningar
- Förlamning
- Primära dysautonomier
- Hypotoni
- Oftalmoplegi
- Parkinsons sjukdom
- Multipel systematrofi
- Shy-Drager syndrom
- Parkinsons sjukdom
- Supranukleär pares, progressiv
Andra studie-ID-nummer
- MSHersheyMC-40726
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 .
Kliniska prövningar på Parkinsonism
-
Inje UniversityDongtan Sacred Heart HospitalHar inte rekryterat ännu
-
Amsterdam UMC, location VUmcParkinsonverenigingOkändParkinsonism, experimentell | Parkinsonism, behandling som vanligtNederländerna
-
Chang Gung Memorial HospitalOkändKolmonoxid-inducerad ParkinsonismTaiwan
-
Chang Gung Memorial HospitalNational Science Council, TaiwanAvslutadVaskulär ParkinsonismTaiwan
-
Ceraxis Health, IncRekryteringRörelsestörningar (inkl parkinsonism)Förenta staterna
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Azienda Socio Sanitaria Territoriale Nord MilanoAktiv, inte rekryterandeParkinsons sjukdom | Sjuksköterska-patientrelationer | Atypisk Parkinsonism | Sjuksköterska Läkarrelationer | Sekundär ParkinsonismItalien
-
The Hong Kong Polytechnic UniversityRekryteringRöstaktiverad Intelligent Personal Assistant (VIPA) intervention för personer med Parkinsons sjukdomParkinsons sjukdom och ParkinsonismHong Kong
-
Parkinson's FoundationIndiana University; The Parkinson Study Group; Navitas Clinical Research,... och andra samarbetspartnersAktiv, inte rekryterandeParkinsons sjukdom och ParkinsonismFörenta staterna
-
University of LuebeckCENTOGENE GmbH RostockOkändParkinsons sjukdom och ParkinsonismTyskland
-
Ain Shams UniversityAvslutadParkinsons sjukdom | Vaskulär ParkinsonismEgypten