Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Knopman, M.D.

Contact us for the latest status

Contact information:

Alzheimer’s Disease Research Center

(507) 284-1324

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff Radford, M.D.

Contact us for the latest status

Contact information:

Memory Disorder Clinic - FL

(904)953-6523

More information

Publications

  • Because of the increasing prevalence of dementia worldwide, combined with limited healthcare expenditures, a better understanding of the main cost drivers of dementia in different care settings is needed. Read More on PubMed
  • The Australian Pharmaceutical Benefits Scheme (PBS) first subsidized cholinesterase inhibitors (CEIs) for Alzheimer's disease in 2001, introducing a novel therapy for a previously untreatable common condition. This study aims to determine Australian rates of CEI use and to assess equality of access to treatment based on socioeconomic status and geographic remoteness. Read More on PubMed
  • Hospitalizations and emergency department (ED) visits for people with Alzheimer's disease and related disorders are of particular concern because many of these patients are physically and mentally frail, and the care delivered in these settings is costly. Using data from the Health and Retirement Study linked with Medicare claims from the period 2000-08, we found that among community-dwelling elderly fee-for-service Medicare beneficiaries, those who had dementia were significantly more likely than those who did not to have a hospitalization (26.7 percent versus 18.7 percent) and an ED visit (34.5 percent versus 25.4 percent) in each year. Comparing nursing home residents who had dementia with those who did not, we found only small differences in hospitalizations (45.8 percent versus 41.9 percent, respectively) and ED use (55.3 percent versus 52.7 percent). As death neared, however, utilization rose sharply across settings and by whether or not beneficiaries had dementia: Nearly 80 percent of community-dwelling decedents were hospitalized, and an equal proportion had at least one ED visit during the last year of life, regardless of dementia. Our research suggests that substantial portions of hospitalizations and ED visits both before and during the last year of life were potentially avoidable. Read More on PubMed
  • The objective of this study was to examine the effect of treatment timing on risk of institutionalization of Medicaid patients with Alzheimer's disease (AD) and to estimate the economic implications of earlier diagnosis and treatment initiation. Read More on PubMed
  • To evaluate the effect of amyloid imaging on clinical decision making. Read More on PubMed
  • Amyloid PET imaging is a novel diagnostic test that can detect in living humans one of the two defining pathologic lesions of Alzheimer disease, amyloid-β deposition in the brain. The Amyloid Imaging Task Force of the Alzheimer's Association and Society for Nuclear Medicine and Molecular Imaging previously published appropriate use criteria for amyloid PET as an important tool for increasing the certainty of a diagnosis of Alzheimer disease in specific patient populations. Here, the task force further clarifies and expands 3 topics discussed in the original paper: first, defining dementia experts and their use of proper documentation to demonstrate the medical necessity of an amyloid PET scan; second, identifying a specific subset of individuals with mild cognitive impairment for whom an amyloid PET scan is appropriate; and finally, developing educational programs to increase awareness of the amyloid PET appropriate use criteria and providing instructions on how this test should be used in the clinical decision-making process. Read More on PubMed
  • Dementia affects a large and growing number of older adults in the United States. The monetary costs attributable to dementia are likely to be similarly large and to continue to increase. Read More on PubMed
  • Dementia is associated with increased rates and often poorer outcomes of hospitalization, including worsening cognitive status. New evidence is needed to determine whether some admissions of persons with dementia might be potentially preventable. Read More on PubMed
  • The added diagnostic value of (11)C-PiB-PET for the assessment of the accumulation of cortical beta-amyloid in memory clinic patients with uncertain diagnosis remains undetermined. Read More on PubMed
  • The National Institute on Aging and the Alzheimer's Association charged a workgroup with the task of revising the 1984 criteria for Alzheimer's disease (AD) dementia. The workgroup sought to ensure that the revised criteria would be flexible enough to be used by both general healthcare providers without access to neuropsychological testing, advanced imaging, and cerebrospinal fluid measures, and specialized investigators involved in research or in clinical trial studies who would have these tools available. We present criteria for all-cause dementia and for AD dementia. We retained the general framework of probable AD dementia from the 1984 criteria. On the basis of the past 27 years of experience, we made several changes in the clinical criteria for the diagnosis. We also retained the term possible AD dementia, but redefined it in a manner more focused than before. Biomarker evidence was also integrated into the diagnostic formulations for probable and possible AD dementia for use in research settings. The core clinical criteria for AD dementia will continue to be the cornerstone of the diagnosis in clinical practice, but biomarker evidence is expected to enhance the pathophysiological specificity of the diagnosis of AD dementia. Much work lies ahead for validating the biomarker diagnosis of AD dementia. Read More on PubMed
  • The National Institute on Aging and the Alzheimer's Association charged a workgroup with the task of developing criteria for the symptomatic predementia phase of Alzheimer's disease (AD), referred to in this article as mild cognitive impairment due to AD. The workgroup developed the following two sets of criteria: (1) core clinical criteria that could be used by healthcare providers without access to advanced imaging techniques or cerebrospinal fluid analysis, and (2) research criteria that could be used in clinical research settings, including clinical trials. The second set of criteria incorporate the use of biomarkers based on imaging and cerebrospinal fluid measures. The final set of criteria for mild cognitive impairment due to AD has four levels of certainty, depending on the presence and nature of the biomarker findings. Considerable work is needed to validate the criteria that use biomarkers and to standardize biomarker analysis for use in community settings. Read More on PubMed
  • To compare the characteristics and outcomes of caregivers of adults with dementia with those of caregivers of adults with cognitive impairment, not dementia (CIND). Read More on PubMed
  • There are no Food and Drug Administration (FDA)-approved medications indicated for the treatment of frontotemporal dementia (FTD). We sought to determine the most commonly used drugs used to treat behavioral variant FTD (bvFTD) in specialized dementia clinics. Read More on PubMed
  • To examine short-term changes in depression and anxiety after receiving a dementia diagnosis. Read More on PubMed
  • The objective of this study was to evaluate donepezil, an acetylcholinesterase inhibitor, in the treatment of frontotemporal dementia (FTD). Read More on PubMed
  • Many patients with Alzheimer's disease are not told their diagnosis. Studies have shown that relatives possess mixed views regarding whether or not patients should be told while elderly peers favour disclosure. Recent studies have shown that patients with diagnosed dementia also favour being told. The present study sought the views of patients prior to diagnosis. Read More on PubMed
  • To determine whether dementia increases medical expenditures, the probability of hospitalization, and potentially preventable hospitalization, controlling for variables including age and comorbidity. Read More on PubMed
  • To update the 1994 practice parameter for the diagnosis of dementia in the elderly. Read More on PubMed
  • This study investigated the prevalence of dementia in a general hospital, reasons for which patients with dementia were admitted, and the relationship between dementia and length of stay, cost, and in-hospital mortality rate. Read More on PubMed
  • To examine attitudes of spouse caregivers about the process of obtaining a diagnosis of a dementing illness, including perceived benefits and obstacles to obtaining a diagnosis and suggestions for improving the process. Read More on PubMed
  • Florbetapir F18 has been approved by the Food and Drug Administration for in vivo assessment of amyloid pathology in patients undergoing evaluation for Alzheimer disease (AD). The aim of this study was to determine the impact of amyloid imaging on the diagnoses and management of patients undergoing evaluation for cognitive decline. Patients were recruited to participate at 19 clinical sites. The site physician provided a provisional diagnosis, an estimate of their diagnostic confidence, and their plan for diagnostic evaluation and management both before and after receiving the results from amyloid imaging with florbetapir F18. Analyses compared the frequency of AD and non-AD diagnoses, plans for ancillary testing, and intended patient management before and after florbetapir imaging. A total of 229 patients participated in the trial (113 amyloid positive, 116 amyloid negative). After receiving the results of the florbetapir scan, diagnosis changed in 125/229, or 54.6% [95% confidence intervals (CI), 48.1%-60.9%], of cases, and diagnostic confidence increased by an average of 21.6% (95% CI, 18.3%-24.8%). A total of 199/229 or 86.9% (95% CI, 81.9%-90.7%) of cases had at least 1 change in their management plan. Intended cholinesterase inhibitor or memantine treatment increased by 17.7% (95% CI, 11.8%-25.8%) of all cases with positive scans and decreased by 23.3% (95% CI, 16.5%-31.8%) of all those with negative scans. Among subjects who had not yet undergone a completed work up, planned brain structural imaging (computed tomographic/magnetic resonance imaging) decreased by 24.4% (95% CI, 17.5%-32.8%) and planned neuropsychological testing decreased by 32.8% (95% CI, 25.0%-41.6%). In summary, amyloid imaging results altered physician's diagnostic thinking, intended testing, and management of patients undergoing evaluation for cognitive decline. Read More on PubMed
  • Little is known about health care use in the cognitive impairment, not dementia (CIND) subpopulation. Using a cohort of 7130 persons aged 71 years or over from the Health and Retirement Survey, we compared mean and total health care use from 2002 to 2008 for those with no cognitive impairment, CIND, or dementia in 2002. Cognitive status was determined using a validated method based on self or proxy interview measures. Health care use was also based on self or proxy reports. On the basis of the Health and Retirement Survey, the CIND subpopulation in 2002 was 5.3 million or 23% of the total population 71 years of age or over. Mean hospital nights was similar and mean nursing home nights was less in persons with CIND compared with persons with dementia. The CIND subpopulation, however, had more total hospital and nursing home nights--71,000 total hospital nights and 223,000 total nursing home nights versus 32,000 hospital nights and 138,000 nursing home nights in the dementia subpopulation. A relatively large population and high health care use result in a large health care impact of the CIND subpopulation. Read More on PubMed
  • Dementia is a growing public health problem for which early detection may be beneficial. Currently, the diagnosis of dementia in primary care is dependent mostly on clinical suspicion on the basis of patient symptoms or caregivers' concerns and is prone to be missed or delayed. We conducted a systematic review of the literature to ascertain the prevalence and contributing factors for missed and delayed dementia diagnoses in primary care. Prevalence of missed and delayed diagnosis was estimated by abstracting quantitative data from studies of diagnostic sensitivity among primary care providers. Possible predictors and contributory factors were determined from the text of quantitative and qualitative studies of patient, caregiver, provider, and system-related barriers. Overall estimates of diagnostic sensitivity varied among studies and seemed to be in part a function of dementia severity, degree of patient impairment, dementia subtype, and frequency of patient-provider contact. Major contributory factors included problems with attitudes and patient-provider communication, educational deficits, and system resource constraints. The true prevalence of missed and delayed diagnoses of dementia is unknown but seems to be high. Until the case for dementia screening becomes more compelling, efforts to promote timely detection should focus on removing barriers to diagnosis. Read More on PubMed

Study Results Summary

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