- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420756
Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study (IDEAS)
Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study: A Coverage With Evidence Development Longitudinal Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The IDEAS Study is an observational, open-label, longitudinal cohort study designed to assess the impact of amyloid PET on patient-oriented outcomes in Medicare beneficiaries with mild cognitive impairment (MCI) or dementia of uncertain etiology. The study falls under the Centers for Medicare & Medicaid Services (CMS) Coverage with Evidence Development (CED) policy. A total of 18,488 Medicare beneficiaries meeting Appropriate Use Criteria (AUC) for amyloid PET will be enrolled over 24 months at sites throughout the United States. Dementia specialists will team with PET facilities able to perform amyloid PET and with trained radiologists/nuclear medicine physicians, all of whom will consent to completing the data requirements and timelines for the study. Amyloid PET will be performed and interpreted at each facility with results provided to the ordering physician for support in further clinical decision making, which will be captured for the study.
Our over-arching hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET will lead to significant changes in patient management, and that this will translate into improved long-term outcomes. We will pursue two specific aims:
Aim 1 investigates the impact of amyloid PET on short-term patient management, by comparing pre-PET intended management (ascertained in a case report form [CRF] prior to PET) to post-PET actual management 90-days post-PET). The primary objective will be to test whether amyloid PET leads to a ≥ 30% change between intended and actual patient management within 90 days in a cumulative endpoint consisting of: Alzheimer's disease (AD) drug therapy, other drug therapy, and counseling about safety and future planning. Secondary objectives will assess the impact of amyloid PET results on clinical diagnosis and prevention of unnecessary diagnostic procedures and treatments.
Aim 2 utilizes Medicare claims data to compare medical outcomes at 12 months for patients enrolled in the longitudinal cohort (amyloid PET-known) with those for a matched control cohort of patients who have never undergone amyloid PET imaging (amyloid PET-naïve). The primary objective will be to determine if amyloid PET in the amyloid PET-known cohort of patients is associated with a ≥ 10% reduction in hospitalizations and emergency room visits in comparison to the matched amyloid PET-naïve patients. Secondary objectives will examine whether knowledge of amyloid PET status reduces hospitalizations related to ambulatory-sensitive conditions, whether the association between amyloid PET knowledge and health outcomes varies by baseline cognitive status (MCI versus dementia) and amyloid status (amyloid positive versus negative). The amyloid PET-naïve cohort will be identified via a matching algorithm where each individual in the amyloid PET-known cohort will be matched to one individual with similar dementia diagnosis, pre-scan dementia-related resource utilization, age, race, gender, ethnicity, geographic location, and comorbid chronic conditions likely to impact cognition or the outcomes of interest seen at the same time as the amyloid PET-known patient (concurrent control).
In pursuing these Aims, we will generate valuable observational data on clinical utility that will inform future use of this technology in diagnostic algorithms, and develop a cohort of patients who undergo amyloid PET and can serve as a foundation to address future research questions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- American College of Radiology Imaging Network
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Philadelphia, Pennsylvania, United States
- Https://Www.Ideas-Study.Org/Site-Locator/
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 and older;
- Medicare beneficiary;
- Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Meets 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.
- Head MRI and/or CT within 24 months prior to enrollment;
- Clinical laboratory assessment (complete blood count [CBC], standard blood chemistry profile, thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to enrollment;
- Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
- English or Spanish speaking (for the purposes of informed consent);
- Willing and able to provide consent. Consent may be by proxy.
Exclusion Criteria:
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- 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).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Hip/pelvic fracture within the 12 months prior to enrollment;
- Body weight exceeds PET scanner weight limit;
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the impact of amyloid PET on the management of patients meeting Appropriate Use Criteria (AUC)
Time Frame: 90 days
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Test whether amyloid PET imaging will lead to a ≥ 30% change between intended and actual patient management within 90 days in a composite measure of at least one of the following:
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90 days
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To assess the impact of amyloid PET on hospital admissions and emergency room visits in patients enrolled in the cohort (amyloid PET-known) compared to matched patients not in the cohort (amyloid PET-naïve) over 12 months
Time Frame: 12 months
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Determine if amyloid PET is associated with a ≥ 10% relative reduction in amyloid PET-known patients in comparison to matched amyloid PET-naïve patients in the following:
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gil D Rabinovici, MD, University of California, San Francisco
Publications and helpful links
General Publications
- Beach TG, Monsell SE, Phillips LE, Kukull W. Accuracy of the clinical diagnosis of Alzheimer disease at National Institute on Aging Alzheimer Disease Centers, 2005-2010. J Neuropathol Exp Neurol. 2012 Apr;71(4):266-73. doi: 10.1097/NEN.0b013e31824b211b.
- Bynum JP, Rabins PV, Weller W, Niefeld M, Anderson GF, Wu AW. The relationship between a dementia diagnosis, chronic illness, medicare expenditures, and hospital use. J Am Geriatr Soc. 2004 Feb;52(2):187-94. doi: 10.1111/j.1532-5415.2004.52054.x.
- Lyketsos CG, Sheppard JM, Rabins PV. Dementia in elderly persons in a general hospital. Am J Psychiatry. 2000 May;157(5):704-7. doi: 10.1176/appi.ajp.157.5.704.
- Phelan EA, Borson S, Grothaus L, Balch S, Larson EB. Association of incident dementia with hospitalizations. JAMA. 2012 Jan 11;307(2):165-72. doi: 10.1001/jama.2011.1964.
- Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629.
- Mendez MF, Shapira JS, McMurtray A, Licht E. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007 Jan;15(1):84-7. doi: 10.1097/01.JGP.0000231744.69631.33.
- Johnson KA, Minoshima S, Bohnen NI, Donohoe KJ, Foster NL, Herscovitch P, Karlawish JH, Rowe CC, Hedrick S, Pappas V, Carrillo MC, Hartley DM. Update on appropriate use criteria for amyloid PET imaging: dementia experts, mild cognitive impairment, and education. J Nucl Med. 2013 Jul;54(7):1011-3. doi: 10.2967/jnumed.113.127068. Epub 2013 Jun 10.
- Thies W and Bleiler L. (2013).
- Naylor MD, Karlawish JH, Arnold SE, et al. (2012).
- Feng Z, Coots LA, Kaganova Y, Wiener JM. Hospital and ED use among Medicare beneficiaries with dementia varies by setting and proximity to death. Health Aff (Millwood). 2014 Apr;33(4):683-90. doi: 10.1377/hlthaff.2013.1179.
- Fisher GG, Franks MM, Plassman BL, Brown SL, Potter GG, Llewellyn D, Rogers MA, Langa KM. Caring for individuals with dementia and cognitive impairment, not dementia: findings from the aging, demographics, and memory study. J Am Geriatr Soc. 2011 Mar;59(3):488-94. doi: 10.1111/j.1532-5415.2010.03304.x.
- Clark DO, Stump TE, Tu W, Miller DK, Langa KM, Unverzagt FW, Callahan CM. Hospital and nursing home use from 2002 to 2008 among U.S. older adults with cognitive impairment, not dementia in 2002. Alzheimer Dis Assoc Disord. 2013 Oct-Dec;27(4):372-8. doi: 10.1097/WAD.0b013e318276994e.
- Schaller S, Mauskopf J, Kriza C, Wahlster P, Kolominsky-Rabas PL. The main cost drivers in dementia: a systematic review. Int J Geriatr Psychiatry. 2015 Feb;30(2):111-29. doi: 10.1002/gps.4198. Epub 2014 Oct 16.
- Connell CM, Gallant MP. Spouse caregivers' attitudes toward obtaining a diagnosis of a dementing illness. J Am Geriatr Soc. 1996 Aug;44(8):1003-9. doi: 10.1111/j.1532-5415.1996.tb01881.x.
- Klein E and Karlawish J. (2013).
- Elson P. Do older adults presenting with memory complaints wish to be told if later diagnosed with Alzheimer's disease? Int J Geriatr Psychiatry. 2006 May;21(5):419-25. doi: 10.1002/gps.1485.
- Carpenter BD, Xiong C, Porensky EK, Lee MM, Brown PJ, Coats M, Johnson D, Morris JC. Reaction to a dementia diagnosis in individuals with Alzheimer's disease and mild cognitive impairment. J Am Geriatr Soc. 2008 Mar;56(3):405-12. doi: 10.1111/j.1532-5415.2007.01600.x. Epub 2008 Jan 5.
- Knopman DS, DeKosky ST, Cummings JL, Chui H, Corey-Bloom J, Relkin N, Small GW, Miller B, Stevens JC. Practice parameter: diagnosis of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2001 May 8;56(9):1143-53. doi: 10.1212/wnl.56.9.1143.
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). 2000.
- Bradford A, Kunik ME, Schulz P, Williams SP, Singh H. Missed and delayed diagnosis of dementia in primary care: prevalence and contributing factors. Alzheimer Dis Assoc Disord. 2009 Oct-Dec;23(4):306-14. doi: 10.1097/WAD.0b013e3181a6bebc.
- Zilkens RR, Duke J, Horner B, Semmens JB, Bruce DG. (2014).
- Bei Hu, Ross L, Neuhaus J, Knopman D, Kramer J, Boeve B, Caselli RJ, Graff-Radford N, Mendez MF, Miller BL, Boxer AL. Off-label medication use in frontotemporal dementia. Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):128-33. doi: 10.1177/1533317509356692. Epub 2010 Feb 1.
- Boxer AL, Knopman DS, Kaufer DI, et al. (2013).
- Doody RS, Thomas RG, Farlow M, et al. Alzheimer's Disease Cooperative Study Steering and G. Solanezumab Study (2014).
- Salloway S, Sperling R, Fox NC, et al. (2014).
- Kirson NY, Hunter CA, Desai U, et al. (2013). "Excess costs associated with a misdiagnosis of Alzheimer's disease among U.S. Medicare beneficiaries with vascular dementia or Parkinson's disease." Alzheimer's Association International Conference. Boston, MA.
- Geldmacher DS, Kirson NY, Birnbaum HG, et al. (2014).
- Johnson KA, Minoshima S, Bohnen NI, et al. (2013).
- Frederiksen KS, Hasselbalch SG, Hejl AM, et al. (2012).
- Ossenkoppele R, Prins ND, Pijnenburg YA, et al. (2013).
- Grundman M, Pontecorvo MJ, Salloway SP, et al. (2013).
- Sanchez-Juan P, Ghosh PM, Hagen J, Gesierich B, Henry M, Grinberg LT, O'Neil JP, Janabi M, Huang EJ, Trojanowski JQ, Vinters HV, Gorno-Tempini M, Seeley WW, Boxer AL, Rosen HJ, Kramer JH, Miller BL, Jagust WJ, Rabinovici GD. Practical utility of amyloid and FDG-PET in an academic dementia center. Neurology. 2014 Jan 21;82(3):230-8. doi: 10.1212/WNL.0000000000000032. Epub 2013 Dec 18.
- Schwarzkopf L, Menn P, Leidl R, et al. (2012).
- Toot S, Devine M, Akporobaro A, Orrell M. (2013).
- Shen HN, Lu CL, Li CY. (2012).
- Lyketsos CG. Prevention of unnecessary hospitalization for patients with dementia: the role of ambulatory care. JAMA. 2012 Jan 11;307(2):197-8. doi: 10.1001/jama.2011.2005. No abstract available.
- Rabinovici GD, Gatsonis C, Apgar C, Chaudhary K, Gareen I, Hanna L, Hendrix J, Hillner BE, Olson C, Lesman-Segev OH, Romanoff J, Siegel BA, Whitmer RA, Carrillo MC. Association of Amyloid Positron Emission Tomography With Subsequent Change in Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia. JAMA. 2019 Apr 2;321(13):1286-1294. doi: 10.1001/jama.2019.2000.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDEAS Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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