Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study

NCT02420756 | Completed

• 1 other identifier: IDEAS Study
• Study Type: observational
• Target: 18,488
• Locations: 1 country
• Sites: 2

Brief Summary

The Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study will establish an open-label, longitudinal cohort study to assess the impact of amyloid PET on patient outcomes. The study will be performed in accordance with the Center for Medicare \& Medicaid Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the underlying cause of cognitive impairment, that this will translate into earlier counseling and interventions in these domains, and that these interventions will lead to improved outcomes.

Conditions

Alzheimer's Disease; Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• To assess the impact of amyloid PET on the management of patients meeting Appropriate Use Criteria (AUC)

  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: 1. AD drug therapy; 2. Other drug therapy; and 3. Counseling about safety and future planning.

  90 days

• 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

  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: 1. Inpatient hospital admissions over 12 months. 2. Emergency room visits over 12 months.

  12 months

Interventions

PET Scan DEVICE

Also known as: Collection of institutional practice PET imaging data

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must be Medicare beneficiaries referred by qualified dementia specialists and must meet AUC for amyloid PET (Johnson et al. 2013).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American College of Radiology: lead
• Alzheimer's Association: collaborator
• American College of Radiology Imaging Network: collaborator

Study Sites (2)

American College of Radiology Imaging Network

Philadelphia, Pennsylvania, 19103, United States

Location

Https://Www.Ideas-Study.Org/Site-Locator/

Philadelphia, Pennsylvania, United States

Location

Related Publications (39)

• 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.

  PMID: 23753186 BACKGROUND

• Thies W and Bleiler L. (2013).

  BACKGROUND

• Naylor MD, Karlawish JH, Arnold SE, et al. (2012).

  BACKGROUND

• 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.

  PMID: 22235087 BACKGROUND

• 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.

  PMID: 24711331 BACKGROUND

• 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.

  PMID: 21391939 BACKGROUND

• 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.

  PMID: 23151595 BACKGROUND

• 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.

  PMID: 25320002 BACKGROUND

• 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.

  PMID: 23550670 BACKGROUND

• 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.

  PMID: 8708288 BACKGROUND

• Klein E and Karlawish J. (2013).

  BACKGROUND

• 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.

  PMID: 16676286 BACKGROUND

• 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.

  PMID: 18194228 BACKGROUND

• 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.

  PMID: 11342678 BACKGROUND

• American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). 2000.

  BACKGROUND

• 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.

  PMID: 21514250 BACKGROUND

• 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.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 19568149 BACKGROUND

• 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.

  PMID: 22437338 BACKGROUND

• Zilkens RR, Duke J, Horner B, Semmens JB, Bruce DG. (2014).

  BACKGROUND

• 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.

  PMID: 20124256 BACKGROUND

• 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.

  PMID: 17194818 BACKGROUND

• Boxer AL, Knopman DS, Kaufer DI, et al. (2013).

  BACKGROUND

• Doody RS, Thomas RG, Farlow M, et al. Alzheimer's Disease Cooperative Study Steering and G. Solanezumab Study (2014).

  BACKGROUND

• Salloway S, Sperling R, Fox NC, et al. (2014).

  BACKGROUND

• 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.

  BACKGROUND

• Geldmacher DS, Kirson NY, Birnbaum HG, et al. (2014).

  BACKGROUND

• Johnson KA, Minoshima S, Bohnen NI, et al. (2013).

  BACKGROUND

• Frederiksen KS, Hasselbalch SG, Hejl AM, Law I, Hojgaard L, Waldemar G. Added Diagnostic Value of (11)C-PiB-PET in Memory Clinic Patients with Uncertain Diagnosis. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):610-21. doi: 10.1159/000345783. Epub 2012 Dec 13.

  PMID: 23341826 BACKGROUND

• Ossenkoppele R, Prins ND, Pijnenburg YA, et al. (2013).

  BACKGROUND

• Grundman M, Pontecorvo MJ, Salloway SP, et al. (2013).

  BACKGROUND

• Sanchez-Juan P, Ghosh PM, Hagen J, et al. (2014).

  BACKGROUND

• 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.

  PMID: 14728626 BACKGROUND

• Schwarzkopf L, Menn P, Leidl R, et al. (2012).

  BACKGROUND

• Toot S, Devine M, Akporobaro A, Orrell M. Causes of hospital admission for people with dementia: a systematic review and meta-analysis. J Am Med Dir Assoc. 2013 Jul;14(7):463-70. doi: 10.1016/j.jamda.2013.01.011. Epub 2013 Mar 17.

  PMID: 23510826 BACKGROUND

• 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.

  PMID: 10784461 BACKGROUND

• Shen HN, Lu CL, Li CY. (2012).

  BACKGROUND

• 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.

  PMID: 22235092 BACKGROUND

• 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.

  PMID: 30938796 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Gil D Rabinovici, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (2)