- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02599753
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
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Taoyuan, 대만, 333
- Chang Gung Memory Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The difference of specific uptake ratio (SUR) of 18F- DTBZ between each diagnostic group
기간: 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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2차 결과 측정
결과 측정 |
기간 |
---|---|
The difference of eigenvalues obtained from diffusion tensor imaging (DTI) between each diagnostic group.
기간: 4 years
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4 years
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기타 결과 측정
결과 측정 |
기간 |
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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.
기간: 4 years
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4 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
18-FDTBZ에 대한 임상 시험
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Enzychem Lifesciences Corporation완전한
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Flanders Medical Research Program완전한
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John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)완전한
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Chang Gung Memorial Hospital완전한전측두엽 치매 | 진행성 핵상 마비 | 알츠하이머병 | 혈관 인지 장애 | 피질 기저 증후군대만