- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00287248
Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain
2014년 3월 6일 업데이트: Danna Jennings, MD, Institute for Neurodegenerative Disorders
Evaluation of [123I] IMPY and SPECT as a Marker of Beta-amyloid Protein Deposition in the Brain of Healthy Subjects and Patients With Alzheimer Disease
This research is designed to obtain efficacy and safety information for 123-I IMPY as an imaging biomarker for Alzheimer's disease (AD).
The distribution of this agent will be measured by obtaining single photon emission computed tomography (SPECT) images of the brain serially over time to determine the relative localization of the radiopharmaceutical in regions of the cortex relative to background regions and develop an optimal technique of radiotracer administration (bolus or bolus with constant infusion).
The researchers will then evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and subsequently serial evaluations of AD patients will be performed to determine if this technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in AD.
연구 개요
상세 설명
All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImanging (MNI) in New Haven, CT.
Approximately 25 patients with mild to moderate Alzheimer's disease (AD) and 20 healthy controls will be recruited to participate in this study.
AD patients will be eligible to participate if they have a diagnosis of AD of less than 3 years duration.
Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects will be asked to undergo either a bolus injection or bolus injection followed by continuous infusion of 123-I IMPY.
Following injection, subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I IMPY in plasma (both protein bound and free) over a 3.5 - 8 hour period.
The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I IMPY.
연구 유형
중재적
등록 (실제)
38
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Institute for Neurodegenerative Disorders
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRA) criteria.
- Mini-Mental Status Exam score > 16 and < 25.
- Patients have a diagnosis of probable AD for < 3 years prior to screening.
Exclusion Criteria:
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
- Subjects with an iodine allergy.
- The subject has a clinically significant clinical laboratory value and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder.
- The subject has received an investigational drug within 60 days before the screening visit.
- Pregnancy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Assess [123I] IMPY & SPECT Imaging
To assess [123I] IMPY & SPECT Imaging
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Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with β-amyloid deposition in AD patients relative to controls
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
기간 |
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Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition
기간: 2 years
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2 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
- Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
- Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 2005 Jun;46(6):1023-7.
- Folstein MF, Folstein SE, McHugh PR.
- Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
- Hardy J, Selkoe DJ. The amyloid hypothesis of Alzheimer's disease: progress and problems on the road to therapeutics. Science. 2002 Jul 19;297(5580):353-6. doi: 10.1126/science.1072994. Erratum In: Science 2002 Sep 27;297(5590):2209.
- McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
- Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol. 1980 May;7(5):486-8. doi: 10.1002/ana.410070516.
- Orgogozo JM, Gilman S, Dartigues JF, Laurent B, Puel M, Kirby LC, Jouanny P, Dubois B, Eisner L, Flitman S, Michel BF, Boada M, Frank A, Hock C. Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization. Neurology. 2003 Jul 8;61(1):46-54. doi: 10.1212/01.wnl.0000073623.84147.a8.
- Hock C, Konietzko U, Streffer JR, Tracy J, Signorell A, Muller-Tillmanns B, Lemke U, Henke K, Moritz E, Garcia E, Wollmer MA, Umbricht D, de Quervain DJ, Hofmann M, Maddalena A, Papassotiropoulos A, Nitsch RM. Antibodies against beta-amyloid slow cognitive decline in Alzheimer's disease. Neuron. 2003 May 22;38(4):547-54. doi: 10.1016/s0896-6273(03)00294-0.
- Bacskai BJ, Kajdasz ST, Christie RH, Carter C, Games D, Seubert P, Schenk D, Hyman BT. Imaging of amyloid-beta deposits in brains of living mice permits direct observation of clearance of plaques with immunotherapy. Nat Med. 2001 Mar;7(3):369-72. doi: 10.1038/85525. No abstract available.
- Bard F, Barbour R, Cannon C, Carretto R, Fox M, Games D, Guido T, Hoenow K, Hu K, Johnson-Wood K, Khan K, Kholodenko D, Lee C, Lee M, Motter R, Nguyen M, Reed A, Schenk D, Tang P, Vasquez N, Seubert P, Yednock T. Epitope and isotype specificities of antibodies to beta -amyloid peptide for protection against Alzheimer's disease-like neuropathology. Proc Natl Acad Sci U S A. 2003 Feb 18;100(4):2023-8. doi: 10.1073/pnas.0436286100. Epub 2003 Feb 3. Erratum In: Proc Natl Acad Sci U S A. 2004 Aug 3;101(3):11526.
- Bard F, Cannon C, Barbour R, Burke RL, Games D, Grajeda H, Guido T, Hu K, Huang J, Johnson-Wood K, Khan K, Kholodenko D, Lee M, Lieberburg I, Motter R, Nguyen M, Soriano F, Vasquez N, Weiss K, Welch B, Seubert P, Schenk D, Yednock T. Peripherally administered antibodies against amyloid beta-peptide enter the central nervous system and reduce pathology in a mouse model of Alzheimer disease. Nat Med. 2000 Aug;6(8):916-9. doi: 10.1038/78682.
- Cai L, Chin FT, Pike VW, Toyama H, Liow JS, Zoghbi SS, Modell K, Briard E, Shetty HU, Sinclair K, Donohue S, Tipre D, Kung MP, Dagostin C, Widdowson DA, Green M, Gao W, Herman MM, Ichise M, Innis RB. Synthesis and evaluation of two 18F-labeled 6-iodo-2-(4'-N,N-dimethylamino)phenylimidazo[1,2-a]pyridine derivatives as prospective radioligands for beta-amyloid in Alzheimer's disease. J Med Chem. 2004 Apr 22;47(9):2208-18. doi: 10.1021/jm030477w.
- Cummings JL. Alzheimer's disease. N Engl J Med. 2004 Jul 1;351(1):56-67. doi: 10.1056/NEJMra040223. No abstract available.
- DeMattos RB, Bales KR, Cummins DJ, Dodart JC, Paul SM, Holtzman DM. Peripheral anti-A beta antibody alters CNS and plasma A beta clearance and decreases brain A beta burden in a mouse model of Alzheimer's disease. Proc Natl Acad Sci U S A. 2001 Jul 17;98(15):8850-5. doi: 10.1073/pnas.151261398. Epub 2001 Jul 3.
- DeMattos RB, Bales KR, Cummins DJ, Paul SM, Holtzman DM. Brain to plasma amyloid-beta efflux: a measure of brain amyloid burden in a mouse model of Alzheimer's disease. Science. 2002 Mar 22;295(5563):2264-7. doi: 10.1126/science.1067568.
- Dodart JC, Bales KR, Gannon KS, Greene SJ, DeMattos RB, Mathis C, DeLong CA, Wu S, Wu X, Holtzman DM, Paul SM. Immunization reverses memory deficits without reducing brain Abeta burden in Alzheimer's disease model. Nat Neurosci. 2002 May;5(5):452-7. doi: 10.1038/nn842.
- Ferrer I, Boada Rovira M, Sanchez Guerra ML, Rey MJ, Costa-Jussa F. Neuropathology and pathogenesis of encephalitis following amyloid-beta immunization in Alzheimer's disease. Brain Pathol. 2004 Jan;14(1):11-20. doi: 10.1111/j.1750-3639.2004.tb00493.x.
- Foster DM. Developing and testing integrated multicompartment models to describe a single-input multiple-output study using the SAAM II software system. Adv Exp Med Biol. 1998;445:59-78. doi: 10.1007/978-1-4899-1959-5_4.
- Fox NC, Black RS, Gilman S, Rossor MN, Griffith SG, Jenkins L, Koller M; AN1792(QS-21)-201 Study. Effects of Abeta immunization (AN1792) on MRI measures of cerebral volume in Alzheimer disease. Neurology. 2005 May 10;64(9):1563-72. doi: 10.1212/01.WNL.0000159743.08996.99.
- Frank RA, Galasko D, Hampel H, Hardy J, de Leon MJ, Mehta PD, Rogers J, Siemers E, Trojanowski JQ; National Institute on Aging Biological Markers Working Group. Biological markers for therapeutic trials in Alzheimer's disease. Proceedings of the biological markers working group; NIA initiative on neuroimaging in Alzheimer's disease. Neurobiol Aging. 2003 Jul-Aug;24(4):521-36. doi: 10.1016/s0197-4580(03)00002-2. No abstract available.
- Gilman S, Koller M, Black RS, Jenkins L, Griffith SG, Fox NC, Eisner L, Kirby L, Rovira MB, Forette F, Orgogozo JM; AN1792(QS-21)-201 Study Team. Clinical effects of Abeta immunization (AN1792) in patients with AD in an interrupted trial. Neurology. 2005 May 10;64(9):1553-62. doi: 10.1212/01.WNL.0000159740.16984.3C.
- Hock C, Konietzko U, Papassotiropoulos A, Wollmer A, Streffer J, von Rotz RC, Davey G, Moritz E, Nitsch RM. Generation of antibodies specific for beta-amyloid by vaccination of patients with Alzheimer disease. Nat Med. 2002 Nov;8(11):1270-5. doi: 10.1038/nm783. Epub 2002 Oct 15.
- Holtzman DM. Role of apoe/Abeta interactions in the pathogenesis of Alzheimer's disease and cerebral amyloid angiopathy. J Mol Neurosci. 2001 Oct;17(2):147-55. doi: 10.1385/JMN:17:2:147.
- Jost BC, Grossberg GT. The natural history of Alzheimer's disease: a brain bank study. J Am Geriatr Soc. 1995 Nov;43(11):1248-55. doi: 10.1111/j.1532-5415.1995.tb07401.x.
- Kung HF, Kung MP, Zhuang ZP, Hou C, Lee CW, Plossl K, Zhuang B, Skovronsky DM, Lee VM, Trojanowski JQ. Iodinated tracers for imaging amyloid plaques in the brain. Mol Imaging Biol. 2003 Nov-Dec;5(6):418-26. doi: 10.1016/j.mibio.2003.09.003.
- Kung MP, Hou C, Zhuang ZP, Cross AJ, Maier DL, Kung HF. Characterization of IMPY as a potential imaging agent for beta-amyloid plaques in double transgenic PSAPP mice. Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1136-45. doi: 10.1007/s00259-004-1487-z. Epub 2004 Mar 9.
- Kung MP, Hou C, Zhuang ZP, Zhang B, Skovronsky D, Trojanowski JQ, Lee VM, Kung HF. IMPY: an improved thioflavin-T derivative for in vivo labeling of beta-amyloid plaques. Brain Res. 2002 Nov 29;956(2):202-10. doi: 10.1016/s0006-8993(02)03436-4.
- Kung MP, Hou C, Zhuang ZP, Skovronsky D, Kung HF. Binding of two potential imaging agents targeting amyloid plaques in postmortem brain tissues of patients with Alzheimer's disease. Brain Res. 2004 Oct 29;1025(1-2):98-105. doi: 10.1016/j.brainres.2004.08.004. Erratum In: Brain Res. 2005 Jan 21;1031(2):302.
- Kung MP, Zhuang ZP, Hou C, Kung HF. Development and evaluation of iodinated tracers targeting amyloid plaques for SPECT imaging. J Mol Neurosci. 2004;24(1):49-53. doi: 10.1385/JMN:24:1:049.
- Kung MP, Zhuang ZP, Hou C, Jin LW, Kung HF. Characterization of radioiodinated ligand binding to amyloid beta plaques. J Mol Neurosci. 2003;20(3):249-54. doi: 10.1385/JMN:20:3:249.
- Loevinger R, Budinger T, Watson E: MIRD Primer for Absorbed Dose Calculations, Society of Nuclear Medicine, 1988.
- Masliah E, Hansen L, Adame A, Crews L, Bard F, Lee C, Seubert P, Games D, Kirby L, Schenk D. Abeta vaccination effects on plaque pathology in the absence of encephalitis in Alzheimer disease. Neurology. 2005 Jan 11;64(1):129-31. doi: 10.1212/01.WNL.0000148590.39911.DF.
- Nicoll JA, Wilkinson D, Holmes C, Steart P, Markham H, Weller RO. Neuropathology of human Alzheimer disease after immunization with amyloid-beta peptide: a case report. Nat Med. 2003 Apr;9(4):448-52. doi: 10.1038/nm840. Epub 2003 Mar 17.
- Okamura N. [In vivo imaging of amyloid plaques in the brain]. Nihon Ronen Igakkai Zasshi. 2004 Mar;41(2):175-8. doi: 10.3143/geriatrics.41.175. Japanese.
- Pfeifer M, Boncristiano S, Bondolfi L, Stalder A, Deller T, Staufenbiel M, Mathews PM, Jucker M. Cerebral hemorrhage after passive anti-Abeta immunotherapy. Science. 2002 Nov 15;298(5597):1379. doi: 10.1126/science.1078259. No abstract available.
- Price DL, Sisodia SS, Borchelt DR. Alzheimer disease--when and why? Nat Genet. 1998 Aug;19(4):314-6. doi: 10.1038/1196. No abstract available.
- Racke MM, Boone LI, Hepburn DL, Parsadainian M, Bryan MT, Ness DK, Piroozi KS, Jordan WH, Brown DD, Hoffman WP, Holtzman DM, Bales KR, Gitter BD, May PC, Paul SM, DeMattos RB. Exacerbation of cerebral amyloid angiopathy-associated microhemorrhage in amyloid precursor protein transgenic mice by immunotherapy is dependent on antibody recognition of deposited forms of amyloid beta. J Neurosci. 2005 Jan 19;25(3):629-36. doi: 10.1523/JNEUROSCI.4337-04.2005.
- Schenk DB, Rydel RE, May P, Little S, Panetta J, Lieberburg I, Sinha S. Therapeutic approaches related to amyloid-beta peptide and Alzheimer's disease. J Med Chem. 1995 Oct 13;38(21):4141-54. doi: 10.1021/jm00021a001. No abstract available.
- Schenk DB, Seubert P, Lieberburg I, Wallace J. beta-peptide immunization: a possible new treatment for Alzheimer disease. Arch Neurol. 2000 Jul;57(7):934-6. doi: 10.1001/archneur.57.7.934. No abstract available.
- Seibyl JP, Zea-Ponce Y, Brenner L, Baldwin RM, Krystal JH, Offord SJ, Mochoviak S, Charney DS, Hoffer PB, Innis RB. Continuous intravenous infusion of iodine-123-IBZM for SPECT determination of human brain dopamine receptor occupancy by antipsychotic agent RWJ-37796. J Nucl Med. 1996 Jan;37(1):11-5.
- Seibyl JP, Woods SW, Zoghbi SS, Baldwin RM, Dey HM, Goddard AW, Zea-Ponce Y, Zubal G, Germine M, Smith EO, et al. Dynamic SPECT imaging of dopamine D2 receptors in human subjects with iodine-123-IBZM. J Nucl Med. 1992 Nov;33(11):1964-71.
- Zhuang ZP, Kung MP, Wilson A, Lee CW, Plossl K, Hou C, Holtzman DM, Kung HF. Structure-activity relationship of imidazo[1,2-a]pyridines as ligands for detecting beta-amyloid plaques in the brain. J Med Chem. 2003 Jan 16;46(2):237-43. doi: 10.1021/jm020351j.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 2월 1일
기본 완료 (실제)
2008년 2월 1일
연구 완료 (실제)
2008년 3월 1일
연구 등록 날짜
최초 제출
2006년 2월 2일
QC 기준을 충족하는 최초 제출
2006년 2월 2일
처음 게시됨 (추정)
2006년 2월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 3월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 3월 6일
마지막으로 확인됨
2014년 3월 1일
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. .
[123I] IMPY & SPECT Imaging에 대한 임상 시험
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Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImaging완전한
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Molecular NeuroImaging완전한
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Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImaging모집하지 않고 적극적으로
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Tomsk National Research Medical Center of the Russian...Uppsala University; The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry초대로 등록
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Institute for Neurodegenerative DisordersMolecular NeuroImaging완전한
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Institute for Neurodegenerative DisordersUnited States Department of Defense완전한
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Assistance Publique - Hôpitaux de ParisAssociation Française contre les Myopathies (AFM), Paris; ARS (Association pour la Recherche... 그리고 다른 협력자들완전한
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prof. dr. Koen Van LaereUniversitaire Ziekenhuizen KU Leuven; KU Leuven; University Hospital, Ghent; Fund for Scientific...아직 모집하지 않음파킨슨병 | 알츠하이머병 | 루이체를 동반한 치매 | MSA - 다중 시스템 위축벨기에