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Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients
Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal Neuroimaging
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Taoyuan, Taiwan, 333
- Chang Gung Memory Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
PD group: 35 subjects with a diagnosis of PD whom must:
- Male or female patients, age range 20~80.
- Patients should not have any clinical evidence of cognitive impairment or ICD.
- Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
PD-MCI group: 35 subjects with a diagnosis of PD with mild cognitive impairment whom must:
- Male or female patients, age range 20~80.
- Patients should be fulfilled the"Diagnostic Criteria for Mild Cognitive Impairment in Parkinson's Disease: Movement Disorder Society Task Force Guidelines" as PD-MCI. (Litvan, 2012; Appendix II).
- Patients should not have any clinical evidence of ICD.
- Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
PDD group: 35 subjects with a diagnosis of PD with dementia whom must:
- Male or female patients, age range 20~80.
- Patients should be fulfilled the "Movement Disorders Society diagnostic criteria of PDD as "possible" or "probable" PDD (Emre, 2006). (Appendix III)
- Patients should not have any clinical evidence of ICD. iv.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
PD-ICD group: 35 subjects with a diagnosis of PD with ICD whom must:
- Male or female patients, age range 20~80.
- Patients should be fulfilled one of the diagnostic criteria or definition in these ICDs: pathological gambling, hypersexuality, compulsive shopping, compulsive eating, punding, and compulsive medication use (Voon, 2009). (Appendix IV).
- Patients should not have any clinical evidence of dementia or cognitive impairment.
- Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
Exclusion Criteria:
- Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
- Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
- Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases (multiple system atrophy, progressive supranuclear palsy).
- History of allergy to radioligands that contain 18F isotope.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 18F-DTBZ for Parkinson's Disease
The participants qualify for the study will return to the clinic at a later date and will have catheter(s) placed for i.v.
administration of 18F- DTBZ for injection.
The participants will receive a single i.v.
bolus of 18F- DTBZ, followed by brain PET imaging of 10 minutes duration, approximately 80 minutes post-dose injection.
Vital signs will be obtained prior to and immediately after the administration of 18F- DTBZ, and at the completion of the imaging session.
Adverse events will be continuously monitored during the imaging session.
The participants experience any adverse event will not be discharged until the event has resolved or stabilized.
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During this study, participants will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV. The proposed dose for this study is based on the investigators' phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The difference of specific uptake ratio (SUR) of 18F- DTBZ between each diagnostic group
Tijdsspanne: 4 years
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The SUVRs of 18F-FP-(+)-DTBZ in ipsilateral caudate, anterior putamen, and bilateral nucleus accumbans were significantly lower in PDD group than those of PD group.
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4 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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The difference of eigenvalues obtained from diffusion tensor imaging (DTI) between each diagnostic group.
Tijdsspanne: 4 years
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4 years
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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The correlation between SURs of 18F-DTBZ and eigenvalues of DTI in each brain regions and the severity of motor or nonmotor symptoms.
Tijdsspanne: 4 years
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4 years
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 101-4874A
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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