Implications for Management of PET Amyloid Classification Technology
NCT ID: NCT02778971
Last Updated: 2023-04-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
41 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-06-30
Study Completion Date
2022-09-30
Brief Summary
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The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction.
The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
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Detailed Description
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The primary purpose of this prospective, observational study is to examine the benefit of \[18F\]Flutemetamol PET/CT scan in clinical practice for early diagnosis of cognitive impairment and identifying Alzheimer's disease (AD) pathology. To accomplish this, when a clinician has ordered an amyloid positron emission tomography (PET) scan, the investigators will assess the impact of \[18F\]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Aims:
Aim 1: To assess the change in diagnosis and management including both care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC).
Aim 2: To assess the change of amyloid PET/CT scans on patient-reported outcomes involving care partner confidence and satisfaction.
Aim 3: To assess the confidence of visual interpretation by using vendor supplied semi-quantitative software to assess amyloid plaque burden.
Hypotheses to be Tested - Synopsis The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Aim 1
1. Amyloid PET will change physician judgment of the likelihood of AD
2. Amyloid PET will change the leading diagnosis in more than 25% of cases
3. Amyloid PET will increase physician diagnostic confidence in the leading diagnosis
4. Amyloid PET will change more than 25% of care practice options from pre-scan management
5. Amyloid PET will change more than 25% of drug management options
Aim 2
1. Care partners are more confident in the diagnosis after the scan than before the scan
2. Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation than previous evaluation
3. Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation with amyloid PET than than the evaluation non-specialists performed without amyloid PET
4. Care partners will find amyloid PET not very burdensome if the doctor finds a scan helpful
5. Based upon their experience with the amyloid PET scan, a majority of the care partners would still agree to have an amyloid PET scan performed if it were requested by the specialist
6. Care partners will find that amyloid PET did not cause an increase in adverse reactions (scan visit) than standard routine clinic visit (post-scan visit)
7. Care partners will find that the diagnostic clinic visit (post-scan visit) did not cause an increase in adverse reactions than the first clinic visit (pre-scan visit)
Aim 3:
1\. Confidence of radiologist / nuclear medicine physician interpretation of scans increases after adding quantitative analysis as compared to qualitative analysis alone
This study will use \[18F\]Flutemetamol-PET imaging to assess and quantify the amyloid plaque burden in patients with mild cognitive impairment (MCI) or dementia of unclear etiology, according to Diagnostic Statistical Manual-IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
The \[18F\]Flutemetamol-PET scans of these study participants will then be assessed using a General Electric (GE) software databases (NeuroMarQ) which contain scan data from healthy control individuals to evaluate for abnormalities in amyloid plaque burden differing from the values expected for individuals in their age range.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Aims:
Aim 1: To assess the change in diagnosis and management including both care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC).
Aim 2: To assess the change of amyloid PET/CT scans on patient-reported outcomes involving care partner confidence and satisfaction.
Aim 3: To assess the confidence of visual interpretation by using vendor supplied semi-quantitative software to assess amyloid plaque burden.
Hypotheses to be Tested - Synopsis The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Aim 1
1. Amyloid PET will change physician judgment of the likelihood of AD
2. Amyloid PET will change the leading diagnosis in more than 25% of cases
3. Amyloid PET will increase physician diagnostic confidence in the leading diagnosis
4. Amyloid PET will change more than 25% of care practice options from pre-scan management
5. Amyloid PET will change more than 25% of drug management options
Aim 2
1. Care partners are more confident in the diagnosis after the scan than before the scan
2. Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation than previous evaluation
3. Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation with amyloid PET than than the evaluation non-specialists performed without amyloid PET
4. Care partners will find amyloid PET not very burdensome if the doctor finds a scan helpful
5. Based upon their experience with the amyloid PET scan, a majority of the care partners would still agree to have an amyloid PET scan performed if it were requested by the specialist
6. Care partners will find that amyloid PET did not cause an increase in adverse reactions (scan visit) than standard routine clinic visit (post-scan visit)
7. Care partners will find that the diagnostic clinic visit (post-scan visit) did not cause an increase in adverse reactions than the first clinic visit (pre-scan visit)
Aim 3:
1\. Confidence of radiologist / nuclear medicine physician interpretation of scans increases after adding quantitative analysis as compared to qualitative analysis alone
This study will use \[18F\]Flutemetamol-PET imaging to assess and quantify the amyloid plaque burden in patients with mild cognitive impairment (MCI) or dementia of unclear etiology, according to Diagnostic Statistical Manual-IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
The \[18F\]Flutemetamol-PET scans of these study participants will then be assessed using a General Electric (GE) software databases (NeuroMarQ) which contain scan data from healthy control individuals to evaluate for abnormalities in amyloid plaque burden differing from the values expected for individuals in their age range.
Conditions
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Mild Cognitive Impairment
Dementia
Alzheimer's Disease
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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Qualifying participants
All consented participants referred by a dementia expert physician to receive an amyloid PET scan with \[18F\]Flutametamol and meeting eligibility criteria will have visual and semi-quantitative software aided scan interpretation, complete care partner questionnaires and providers will document diagnosis, diagnostic confidence, and management plan before and after the scan.
[18F]Flutemetamol
Intervention Type
DRUG
amyloid PET imaging with \[18F\]Flutemetamol and subsequent modification of diagnosis and management
Interventions
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[18F]Flutemetamol
amyloid PET imaging with \[18F\]Flutemetamol and subsequent modification of diagnosis and management
Intervention Type
DRUG
Other Intervention Names
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Vizamyl
Eligibility Criteria
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Inclusion Criteria
* Patients must be 45 to 90 years of age for inclusion in this research study.
* Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
* Meets Appropriate Use Criteria (AUC)
* Cognitive complaint verified by objectively confirmed cognitive impairment;
* The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below;
* Alzheimer's disease is a diagnostic consideration;
* Knowledge of amyloid PET status is expected to alter diagnosis and management.
* MRI and/or CT of the brain within 12 months prior to enrollment;
* Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH), vitamin B12;
* Patient must agree to have clinical and radiographic endpoints and the results of and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
* Patient must be postmenopausal for a minimum of one year, surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test performed within 24 hours prior to research PET imaging.
* All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
* Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
* Meets Appropriate Use Criteria (AUC)
* Cognitive complaint verified by objectively confirmed cognitive impairment;
* The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below;
* Alzheimer's disease is a diagnostic consideration;
* Knowledge of amyloid PET status is expected to alter diagnosis and management.
* MRI and/or CT of the brain within 12 months prior to enrollment;
* Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH), vitamin B12;
* Patient must agree to have clinical and radiographic endpoints and the results of and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
* Patient must be postmenopausal for a minimum of one year, surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test performed within 24 hours prior to research PET imaging.
* All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
Exclusion Criteria
* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
* Adult patients who require monitored anesthesia for PET scanning.
* Patients who are too claustrophobic to undergo PET imaging.
* Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.
* Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
* Subject's scans being ordered for one of the following reasons:
* Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers;
* Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening)
* Currently pregnant
* Patients who are unwilling to know the results of their PET imaging scan.
* Adult patients who require monitored anesthesia for PET scanning.
* Patients who are too claustrophobic to undergo PET imaging.
* Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.
* Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
* Subject's scans being ordered for one of the following reasons:
* Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers;
* Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening)
* Currently pregnant
* Patients who are unwilling to know the results of their PET imaging scan.
Minimum Eligible Age
45 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Norman L. Foster, M.D.
Role: PRINCIPAL_INVESTIGATOR
Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine
John M. Hoffman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Radiology and Neurology Director of Nuclear Medicine; Director: Center for Quantitative Cancer Imaging Huntsman Cancer Institute University of Utah School of Medicine
Locations
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Center for Alzheimer's Care, Imaging & Research
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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Naylor MD, Karlawish JH, Arnold SE, Khachaturian AS, Khachaturian ZS, Lee VM, Baumgart M, Banerjee S, Beck C, Blennow K, Brookmeyer R, Brunden KR, Buckwalter KC, Comer M, Covinsky K, Feinberg LF, Frisoni G, Green C, Guimaraes RM, Gwyther LP, Hefti FF, Hutton M, Kawas C, Kent DM, Kuller L, Langa KM, Mahley RW, Maslow K, Masters CL, Meier DE, Neumann PJ, Paul SM, Petersen RC, Sager MA, Sano M, Schenk D, Soares H, Sperling RA, Stahl SM, van Deerlin V, Stern Y, Weir D, Wolk DA, Trojanowski JQ. Advancing Alzheimer's disease diagnosis, treatment, and care: recommendations from the Ware Invitational Summit. Alzheimers Dement. 2012 Sep;8(5):445-52. doi: 10.1016/j.jalz.2012.08.001.
Reference Type
BACKGROUND
Albert MS, Blacker D. Mild cognitive impairment and dementia. Annu Rev Clin Psychol. 2006;2:379-88. doi: 10.1146/annurev.clinpsy.1.102803.144039.
Reference Type
BACKGROUND
Mitchell AJ. The clinical significance of subjective memory complaints in the diagnosis of mild cognitive impairment and dementia: a meta-analysis. Int J Geriatr Psychiatry. 2008 Nov;23(11):1191-202. doi: 10.1002/gps.2053.
Reference Type
BACKGROUND
Matsuda T, Takayama T, Tashiro M, Nakamura Y, Ohashi Y, Shimozuma K. Mild cognitive impairment after adjuvant chemotherapy in breast cancer patients--evaluation of appropriate research design and methodology to measure symptoms. Breast Cancer. 2005;12(4):279-87. doi: 10.2325/jbcs.12.279.
Reference Type
BACKGROUND
Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
Reference Type
BACKGROUND
Braak H, Braak E. Diagnostic criteria for neuropathologic assessment of Alzheimer's disease. Neurobiol Aging. 1997 Jul-Aug;18(4 Suppl):S85-8. doi: 10.1016/s0197-4580(97)00062-6.
Reference Type
BACKGROUND
Selkoe DJ. Physiological production of the beta-amyloid protein and the mechanism of Alzheimer's disease. Trends Neurosci. 1993 Oct;16(10):403-9. doi: 10.1016/0166-2236(93)90008-a.
Reference Type
BACKGROUND
Naslund J, Haroutunian V, Mohs R, Davis KL, Davies P, Greengard P, Buxbaum JD. Correlation between elevated levels of amyloid beta-peptide in the brain and cognitive decline. JAMA. 2000 Mar 22-29;283(12):1571-7. doi: 10.1001/jama.283.12.1571.
Reference Type
BACKGROUND
Arendash GW, Gordon MN, Diamond DM, Austin LA, Hatcher JM, Jantzen P, DiCarlo G, Wilcock D, Morgan D. Behavioral assessment of Alzheimer's transgenic mice following long-term Abeta vaccination: task specificity and correlations between Abeta deposition and spatial memory. DNA Cell Biol. 2001 Nov;20(11):737-44. doi: 10.1089/10445490152717604.
Reference Type
BACKGROUND
Mosconi L, McHugh PF. FDG- and amyloid-PET in Alzheimer's disease: is the whole greater than the sum of the parts? Q J Nucl Med Mol Imaging. 2011 Jun;55(3):250-64.
Reference Type
BACKGROUND
Okello A, Koivunen J, Edison P, Archer HA, Turkheimer FE, Nagren K, Bullock R, Walker Z, Kennedy A, Fox NC, Rossor MN, Rinne JO, Brooks DJ. Conversion of amyloid positive and negative MCI to AD over 3 years: an 11C-PIB PET study. Neurology. 2009 Sep 8;73(10):754-60. doi: 10.1212/WNL.0b013e3181b23564. Epub 2009 Jul 8.
Reference Type
BACKGROUND
Resnick SM, Sojkova J, Zhou Y, An Y, Ye W, Holt DP, Dannals RF, Mathis CA, Klunk WE, Ferrucci L, Kraut MA, Wong DF. Longitudinal cognitive decline is associated with fibrillar amyloid-beta measured by [11C]PiB. Neurology. 2010 Mar 9;74(10):807-15. doi: 10.1212/WNL.0b013e3181d3e3e9. Epub 2010 Feb 10.
Reference Type
BACKGROUND
Wolk DA, Price JC, Saxton JA, Snitz BE, James JA, Lopez OL, Aizenstein HJ, Cohen AD, Weissfeld LA, Mathis CA, Klunk WE, De-Kosky ST. Amyloid imaging in mild cognitive impairment subtypes. Ann Neurol. 2009 May;65(5):557-68. doi: 10.1002/ana.21598.
Reference Type
BACKGROUND
Jack CR Jr, Knopman DS, Jagust WJ, Shaw LM, Aisen PS, Weiner MW, Petersen RC, Trojanowski JQ. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade. Lancet Neurol. 2010 Jan;9(1):119-28. doi: 10.1016/S1474-4422(09)70299-6.
Reference Type
BACKGROUND
Rowe CC, Villemagne VL. Amyloid imaging with PET in early Alzheimer disease diagnosis. Med Clin North Am. 2013 May;97(3):377-98. doi: 10.1016/j.mcna.2012.12.017.
Reference Type
BACKGROUND
Thal LJ, Kantarci K, Reiman EM, Klunk WE, Weiner MW, Zetterberg H, Galasko D, Pratico D, Griffin S, Schenk D, Siemers E. The role of biomarkers in clinical trials for Alzheimer disease. Alzheimer Dis Assoc Disord. 2006 Jan-Mar;20(1):6-15. doi: 10.1097/01.wad.0000191420.61260.a8.
Reference Type
BACKGROUND
Nichols L, Pike VW, Cai L, Innis RB. Imaging and in vivo quantitation of beta-amyloid: an exemplary biomarker for Alzheimer's disease? Biol Psychiatry. 2006 May 15;59(10):940-7. doi: 10.1016/j.biopsych.2005.12.004. Epub 2006 Feb 17.
Reference Type
BACKGROUND
Yankner BA, Dawes LR, Fisher S, Villa-Komaroff L, Oster-Granite ML, Neve RL. Neurotoxicity of a fragment of the amyloid precursor associated with Alzheimer's disease. Science. 1989 Jul 28;245(4916):417-20. doi: 10.1126/science.2474201.
Reference Type
BACKGROUND
Small GW, Kepe V, Ercoli LM, Siddarth P, Bookheimer SY, Miller KJ, Lavretsky H, Burggren AC, Cole GM, Vinters HV, Thompson PM, Huang SC, Satyamurthy N, Phelps ME, Barrio JR. PET of brain amyloid and tau in mild cognitive impairment. N Engl J Med. 2006 Dec 21;355(25):2652-63. doi: 10.1056/NEJMoa054625.
Reference Type
BACKGROUND
Mathis CA, Wang Y, Holt DP, Huang GF, Debnath ML, Klunk WE. Synthesis and evaluation of 11C-labeled 6-substituted 2-arylbenzothiazoles as amyloid imaging agents. J Med Chem. 2003 Jun 19;46(13):2740-54. doi: 10.1021/jm030026b.
Reference Type
BACKGROUND
Verhoeff NP, Wilson AA, Takeshita S, Trop L, Hussey D, Singh K, Kung HF, Kung MP, Houle S. In-vivo imaging of Alzheimer disease beta-amyloid with [11C]SB-13 PET. Am J Geriatr Psychiatry. 2004 Nov-Dec;12(6):584-95. doi: 10.1176/appi.ajgp.12.6.584.
Reference Type
BACKGROUND
Price JC, Klunk WE, Lopresti BJ, Lu X, Hoge JA, Ziolko SK, Holt DP, Meltzer CC, DeKosky ST, Mathis CA. Kinetic modeling of amyloid binding in humans using PET imaging and Pittsburgh Compound-B. J Cereb Blood Flow Metab. 2005 Nov;25(11):1528-47. doi: 10.1038/sj.jcbfm.9600146.
Reference Type
BACKGROUND
Mintun MA. Utilizing advanced imaging and surrogate markers across the spectrum of Alzheimer's disease. CNS Spectr. 2005 Nov;10(11 Suppl 18):13-6. doi: 10.1017/s1092852900014188.
Reference Type
BACKGROUND
Rabinovici GD, Furst AJ, O'Neil JP, Racine CA, Mormino EC, Baker SL, Chetty S, Patel P, Pagliaro TA, Klunk WE, Mathis CA, Rosen HJ, Miller BL, Jagust WJ. 11C-PIB PET imaging in Alzheimer disease and frontotemporal lobar degeneration. Neurology. 2007 Apr 10;68(15):1205-12. doi: 10.1212/01.wnl.0000259035.98480.ed.
Reference Type
BACKGROUND
Koole M, Lewis DM, Buckley C, Nelissen N, Vandenbulcke M, Brooks DJ, Vandenberghe R, Van Laere K. Whole-body biodistribution and radiation dosimetry of 18F-GE067: a radioligand for in vivo brain amyloid imaging. J Nucl Med. 2009 May;50(5):818-22. doi: 10.2967/jnumed.108.060756. Epub 2009 Apr 16.
Reference Type
BACKGROUND
Nelissen N, Van Laere K, Thurfjell L, Owenius R, Vandenbulcke M, Koole M, Bormans G, Brooks DJ, Vandenberghe R. Phase 1 study of the Pittsburgh compound B derivative 18F-flutemetamol in healthy volunteers and patients with probable Alzheimer disease. J Nucl Med. 2009 Aug;50(8):1251-9. doi: 10.2967/jnumed.109.063305. Epub 2009 Jul 17.
Reference Type
BACKGROUND
Vandenberghe R, Van Laere K, Ivanoiu A, Salmon E, Bastin C, Triau E, Hasselbalch S, Law I, Andersen A, Korner A, Minthon L, Garraux G, Nelissen N, Bormans G, Buckley C, Owenius R, Thurfjell L, Farrar G, Brooks DJ. 18F-flutemetamol amyloid imaging in Alzheimer disease and mild cognitive impairment: a phase 2 trial. Ann Neurol. 2010 Sep;68(3):319-29. doi: 10.1002/ana.22068.
Reference Type
BACKGROUND
Wolk DA, Grachev ID, Buckley C, Kazi H, Grady MS, Trojanowski JQ, Hamilton RH, Sherwin P, McLain R, Arnold SE. Association between in vivo fluorine 18-labeled flutemetamol amyloid positron emission tomography imaging and in vivo cerebral cortical histopathology. Arch Neurol. 2011 Nov;68(11):1398-403. doi: 10.1001/archneurol.2011.153. Epub 2011 Jul 11.
Reference Type
BACKGROUND
Rinne JO, Wong DF, Wolk DA, Leinonen V, Arnold SE, Buckley C, Smith A, McLain R, Sherwin PF, Farrar G, Kailajarvi M, Grachev ID. [(18)F]Flutemetamol PET imaging and cortical biopsy histopathology for fibrillar amyloid beta detection in living subjects with normal pressure hydrocephalus: pooled analysis of four studies. Acta Neuropathol. 2012 Dec;124(6):833-45. doi: 10.1007/s00401-012-1051-z. Epub 2012 Oct 10.
Reference Type
BACKGROUND
Thurfjell L, Lotjonen J, Lundqvist R, Koikkalainen J, Soininen H, Waldemar G, Brooks DJ, Vandenberghe R. Combination of biomarkers: PET [18F]flutemetamol imaging and structural MRI in dementia and mild cognitive impairment. Neurodegener Dis. 2012;10(1-4):246-9. doi: 10.1159/000335381. Epub 2012 Feb 1.
Reference Type
BACKGROUND
Adamczuk K, De Weer AS, Nelissen N, Chen K, Sleegers K, Bettens K, Van Broeckhoven C, Vandenbulcke M, Thiyyagura P, Dupont P, Van Laere K, Reiman EM, Vandenberghe R. Polymorphism of brain derived neurotrophic factor influences beta amyloid load in cognitively intact apolipoprotein E epsilon4 carriers. Neuroimage Clin. 2013 Apr 11;2:512-20. doi: 10.1016/j.nicl.2013.04.001. eCollection 2013.
Reference Type
BACKGROUND
Duara R, Loewenstein DA, Shen Q, Barker W, Potter E, Varon D, Heurlin K, Vandenberghe R, Buckley C. Amyloid positron emission tomography with (18)F-flutemetamol and structural magnetic resonance imaging in the classification of mild cognitive impairment and Alzheimer's disease. Alzheimers Dement. 2013 May;9(3):295-301. doi: 10.1016/j.jalz.2012.01.006. Epub 2012 Nov 22.
Reference Type
BACKGROUND
Duff K, Foster NL, Dennett K, Hammers DB, Zollinger LV, Christian PE, Butterfield RI, Beardmore BE, Wang AY, Morton KA, Hoffman JM. Amyloid deposition and cognition in older adults: the effects of premorbid intellect. Arch Clin Neuropsychol. 2013 Nov;28(7):665-71. doi: 10.1093/arclin/act047. Epub 2013 Jun 30.
Reference Type
BACKGROUND
Leinonen V, Rinne JO, Virtanen KA, Eskola O, Rummukainen J, Huttunen J, von Und Zu Fraunberg M, Nerg O, Koivisto AM, Rinne J, Jaaskelainen JE, Buckley C, Smith A, Jones PA, Sherwin P, Farrar G, McLain R, Kailajarvi M, Heurling K, Grachev ID. Positron emission tomography with [18F]flutemetamol and [11C]PiB for in vivo detection of cerebral cortical amyloid in normal pressure hydrocephalus patients. Eur J Neurol. 2013 Jul;20(7):1043-52. doi: 10.1111/ene.12102. Epub 2013 Feb 11.
Reference Type
BACKGROUND
Rinne JO, Frantzen J, Leinonen V, Lonnrot K, Laakso A, Virtanen KA, Solin O, Kotkansalo A, Koivisto A, Sajanti J, Karppinen A, Lehto H, Rummukainen J, Buckley C, Smith A, Jones PA, Sherwin P, Farrar G, McLain R, Kailajarvi M, Grachev ID. Prospective flutemetamol positron emission tomography and histopathology in normal pressure hydrocephalus. Neurodegener Dis. 2014;13(4):237-45. doi: 10.1159/000355256. Epub 2013 Nov 27.
Reference Type
BACKGROUND
Wong DF, Moghekar AR, Rigamonti D, Brasic JR, Rousset O, Willis W, Buckley C, Smith A, Gok B, Sherwin P, Grachev ID. An in vivo evaluation of cerebral cortical amyloid with [18F]flutemetamol using positron emission tomography compared with parietal biopsy samples in living normal pressure hydrocephalus patients. Mol Imaging Biol. 2013 Apr;15(2):230-7. doi: 10.1007/s11307-012-0583-x.
Reference Type
BACKGROUND
Hatashita S, Yamasaki H, Suzuki Y, Tanaka K, Wakebe D, Hayakawa H. [18F]Flutemetamol amyloid-beta PET imaging compared with [11C]PIB across the spectrum of Alzheimer's disease. Eur J Nucl Med Mol Imaging. 2014 Feb;41(2):290-300. doi: 10.1007/s00259-013-2564-y. Epub 2013 Oct 2.
Reference Type
BACKGROUND
Pietrzak RH, Lim YY, Neumeister A, Ames D, Ellis KA, Harrington K, Lautenschlager NT, Restrepo C, Martins RN, Masters CL, Villemagne VL, Rowe CC, Maruff P; Australian Imaging, Biomarkers, and Lifestyle Research Group. Amyloid-beta, anxiety, and cognitive decline in preclinical Alzheimer disease: a multicenter, prospective cohort study. JAMA Psychiatry. 2015 Mar;72(3):284-91. doi: 10.1001/jamapsychiatry.2014.2476.
Reference Type
BACKGROUND
Senda M, Brooks DJ, Farrar G, Somer EJ, Paterson CL, Sasaki M, McParland BJ. The clinical safety, biodistribution and internal radiation dosimetry of flutemetamol ((1)(8)F) injection in healthy Japanese adult volunteers. Ann Nucl Med. 2015 Aug;29(7):627-35. doi: 10.1007/s12149-015-0986-2. Epub 2015 Jun 5.
Reference Type
BACKGROUND
Curtis C, Gamez JE, Singh U, Sadowsky CH, Villena T, Sabbagh MN, Beach TG, Duara R, Fleisher AS, Frey KA, Walker Z, Hunjan A, Holmes C, Escovar YM, Vera CX, Agronin ME, Ross J, Bozoki A, Akinola M, Shi J, Vandenberghe R, Ikonomovic MD, Sherwin PF, Grachev ID, Farrar G, Smith AP, Buckley CJ, McLain R, Salloway S. Phase 3 trial of flutemetamol labeled with radioactive fluorine 18 imaging and neuritic plaque density. JAMA Neurol. 2015 Mar;72(3):287-94. doi: 10.1001/jamaneurol.2014.4144.
Reference Type
BACKGROUND
Kelloff GJ, Hoffman JM, Johnson B, Scher HI, Siegel BA, Cheng EY, Cheson BD, O'shaughnessy J, Guyton KZ, Mankoff DA, Shankar L, Larson SM, Sigman CC, Schilsky RL, Sullivan DC. Progress and promise of FDG-PET imaging for cancer patient management and oncologic drug development. Clin Cancer Res. 2005 Apr 15;11(8):2785-808. doi: 10.1158/1078-0432.CCR-04-2626.
Reference Type
BACKGROUND
Patlak CS, Blasberg RG, Fenstermacher JD. Graphical evaluation of blood-to-brain transfer constants from multiple-time uptake data. J Cereb Blood Flow Metab. 1983 Mar;3(1):1-7. doi: 10.1038/jcbfm.1983.1.
Reference Type
BACKGROUND
Patlak CS, Blasberg RG. Graphical evaluation of blood-to-brain transfer constants from multiple-time uptake data. Generalizations. J Cereb Blood Flow Metab. 1985 Dec;5(4):584-90. doi: 10.1038/jcbfm.1985.87.
Reference Type
BACKGROUND
Mintun MA, Larossa GN, Sheline YI, Dence CS, Lee SY, Mach RH, Klunk WE, Mathis CA, DeKosky ST, Morris JC. [11C]PIB in a nondemented population: potential antecedent marker of Alzheimer disease. Neurology. 2006 Aug 8;67(3):446-52. doi: 10.1212/01.wnl.0000228230.26044.a4.
Reference Type
BACKGROUND
Vlassenko AG, Mintun MA, Xiong C, Sheline YI, Goate AM, Benzinger TL, Morris JC. Amyloid-beta plaque growth in cognitively normal adults: longitudinal [11C]Pittsburgh compound B data. Ann Neurol. 2011 Nov;70(5):857-61. doi: 10.1002/ana.22608.
Reference Type
BACKGROUND
Rowe CC, Ellis KA, Rimajova M, Bourgeat P, Pike KE, Jones G, Fripp J, Tochon-Danguy H, Morandeau L, O'Keefe G, Price R, Raniga P, Robins P, Acosta O, Lenzo N, Szoeke C, Salvado O, Head R, Martins R, Masters CL, Ames D, Villemagne VL. Amyloid imaging results from the Australian Imaging, Biomarkers and Lifestyle (AIBL) study of aging. Neurobiol Aging. 2010 Aug;31(8):1275-83. doi: 10.1016/j.neurobiolaging.2010.04.007. Epub 2010 May 15.
Reference Type
BACKGROUND
Fleisher AS, Chen K, Liu X, Roontiva A, Thiyyagura P, Ayutyanont N, Joshi AD, Clark CM, Mintun MA, Pontecorvo MJ, Doraiswamy PM, Johnson KA, Skovronsky DM, Reiman EM. Using positron emission tomography and florbetapir F18 to image cortical amyloid in patients with mild cognitive impairment or dementia due to Alzheimer disease. Arch Neurol. 2011 Nov;68(11):1404-11. doi: 10.1001/archneurol.2011.150. Epub 2011 Jul 11.
Reference Type
BACKGROUND
Chetelat G, La Joie R, Villain N, Perrotin A, de La Sayette V, Eustache F, Vandenberghe R. Amyloid imaging in cognitively normal individuals, at-risk populations and preclinical Alzheimer's disease. Neuroimage Clin. 2013 Mar 5;2:356-65. doi: 10.1016/j.nicl.2013.02.006. eCollection 2013.
Reference Type
BACKGROUND
Lundqvist R, Lilja J, Thomas BA, Lotjonen J, Villemagne VL, Rowe CC, Thurfjell L. Implementation and validation of an adaptive template registration method for 18F-flutemetamol imaging data. J Nucl Med. 2013 Aug;54(8):1472-8. doi: 10.2967/jnumed.112.115006. Epub 2013 Jun 5.
Reference Type
BACKGROUND
Thal D, Beach TG, Zanette M, Heurling K, Buckley C, Smith A. [18F] Flutemetamol amyloid PET in Symptomatic Alzheimer's Disease (AD) and Pathologically Preclinical AD (P-Read) in Comparison to Non-AD Controls: Impact of Cerebral Amyloid Angiopathy. Alzheimer's & Dementia. 2014;10(4):P130.
Reference Type
BACKGROUND
Rowe CC, Dore V, Bourgeat P, et al. Higher AB Burden in Healthy APOE-E4 Carriers is Associated with Subjective Memory Complaints: Results from the Flutemetamol and PIB AIPL Cohorts. Alzheimer's & Dementia. 2014;10(4):P186-P187.
Reference Type
BACKGROUND
Adamczuk K, Schaeverbeke J, Nelissen N, et al. Comparison between semiquantitative measures and reader concordance of amyloid load based on 18F-flutemetamol versus 11C-PIB in cognitively intact older adults. Alzheimer's & Dementia. 2014;10(4):P143.
Reference Type
BACKGROUND
Leinonen V, Rinne JO, Wong DF, Wolk DA, Trojanowski JQ, Sherwin PF, Smith A, Heurling K, Su M, Grachev ID. Diagnostic effectiveness of quantitative [(1)(8)F]flutemetamol PET imaging for detection of fibrillar amyloid beta using cortical biopsy histopathology as the standard of truth in subjects with idiopathic normal pressure hydrocephalus. Acta Neuropathol Commun. 2014 Apr 22;2:46. doi: 10.1186/2051-5960-2-46.
Reference Type
BACKGROUND
Heurling K, Miki T, Shimada H, et al. Blinded Visual Evaluation and Quantitative SUVR Threshold Classification of [18F]Flutemetamol PET Images in Japanese SUBJECTS. Alzheimer's & Dementia. 2014;10(4):P15.
Reference Type
BACKGROUND
Wolk DA, Duara R, Sadowsky C. [18F]Flutemetamol Amyloid PET Imaging: Outcome of a Phase III Study in Subjects with Amnestic Mild Cognitive Impairment after a 3-Year Follow-Up. Alzheimer's & Dementia. 2014;4(10):P898.
Reference Type
BACKGROUND
Hanseeuw B, Dricot L, Grandin C, Lhommel R, Quenon L, Ivanoiu A. Regional Brain Metabolism and Cortical Thickness in F18-Flutemetamol Amyloid-Positive Versus-Negative Mild Cognitve Impariment Patients. Alzheimer's & Dementia. 2014;10(4):P167-P168.
Reference Type
BACKGROUND
Schaeverbeke J, Adamczuk K, Bruffaerts R, et al. Comparison of 18F-Flutemetamol Uptake and CSF Measurements in Cognitively Intact Older Individuals. Alzheimer's & Dementia. 2014;4(10):P144.
Reference Type
BACKGROUND
AAPM Report No. 96: The Measurement, Reporting, and Management of Radiation Dose in CT. Report of AAPM Task Group 23 of the Diagnostic Imaging Council CT Committee. College Park, MD: American Association of Physicists in Medicine; 2008.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00084919
Identifier Type: -
Identifier Source: org_study_id
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