Association of Amyloid Positron Emission Tomography With Subsequent Change in Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia

Abstract

<div class="section"> <a class="named-anchor" id="ab-joi190021-1"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e460">Question</h5> <p id="d1210319e462">Is use of amyloid positron emission tomography (PET) associated with subsequent change in the management of patients with mild cognitive impairment (MCI) or dementia of uncertain etiology? </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-2"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e465">Findings</h5> <p id="d1210319e467">In this longitudinal study that included 11 409 participants with MCI or dementia of uncertain cause, patient management 90 days after amyloid PET changed (compared with the pre-PET plan) in 60.2% of patients with MCI and 63.5% of patients with dementia. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-3"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e470">Meaning</h5> <p id="d1210319e472">Amyloid PET was associated with changes in the subsequent management of diagnostically challenging patients with cognitive disorders. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-4"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e476">Importance</h5> <p id="d1210319e478">Amyloid positron emission tomography (PET) detects amyloid plaques in the brain, a core neuropathological feature of Alzheimer disease. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-5"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e481">Objective</h5> <p id="d1210319e483">To determine if amyloid PET is associated with subsequent changes in the management of patients with mild cognitive impairment (MCI) or dementia of uncertain etiology. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-6"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e486">Design, Setting, and Participants</h5> <p id="d1210319e488">The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) study was a single-group, multisite longitudinal study that assessed the association between amyloid PET and subsequent changes in clinical management for Medicare beneficiaries with MCI or dementia. Participants were required to meet published appropriate use criteria stating that etiology of cognitive impairment was unknown, Alzheimer disease was a diagnostic consideration, and knowledge of PET results was expected to change diagnosis and management. A total of 946 dementia specialists at 595 US sites enrolled 16 008 patients between February 2016 and September 2017. Patients were followed up through January 2018. Dementia specialists documented their diagnosis and management plan before PET and again 90 (±30) days after PET. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-7"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e491">Exposures</h5> <p id="d1210319e493">Participants underwent amyloid PET at 343 imaging centers.</p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-8"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e496">Main Outcomes and Measures</h5> <p id="d1210319e498">The primary end point was change in management between the pre- and post-PET visits, as assessed by a composite outcome that included Alzheimer disease drug therapy, other drug therapy, and counseling about safety and future planning. The study was powered to detect a 30% or greater change in the MCI and dementia groups. One of 2 secondary end points is reported: the proportion of changes in diagnosis (from Alzheimer disease to non–Alzheimer disease and vice versa) between pre- and post-PET visits. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-9"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e501">Results</h5> <p id="d1210319e503">Among 16 008 registered participants, 11 409 (71.3%) completed study procedures and were included in the analysis (median age, 75 years [interquartile range, 71-80]; 50.9% women; 60.5% with MCI). Amyloid PET results were positive in 3817 patients with MCI (55.3%) and 3154 patients with dementia (70.1%). The composite end point changed in 4159 of 6905 patients with MCI (60.2% [95% CI, 59.1%-61.4%]) and 2859 of 4504 patients with dementia (63.5% [95% CI, 62.1%-64.9%]), significantly exceeding the 30% threshold in each group ( <i>P</i> &lt; .001, 1-sided). The etiologic diagnosis changed from Alzheimer disease to non–Alzheimer disease in 2860 of 11 409 patients (25.1% [95% CI, 24.3%-25.9%]) and from non–Alzheimer disease to Alzheimer disease in 1201 of 11 409 (10.5% [95% CI, 10.0%-11.1%]). </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-10"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e509">Conclusions and Relevance</h5> <p id="d1210319e511">Among Medicare beneficiaries with MCI or dementia of uncertain etiology evaluated by dementia specialists, the use of amyloid PET was associated with changes in clinical management within 90 days. Further research is needed to determine whether amyloid PET is associated with improved clinical outcomes. </p> </div><div class="section"> <a class="named-anchor" id="ab-joi190021-11"> <!-- named anchor --> </a> <h5 class="section-title" id="d1210319e514">Trial Registration</h5> <p id="d1210319e516">ClinicalTrials.gov Identifier: <a data-untrusted="" href="https://clinicaltrials.gov/ct2/show/NCT02420756" id="d1210319e518" target="xrefwindow">NCT02420756</a> </p> </div><p class="first" id="d1210319e522">In an attempt to understand if amyloid PET imaging improves the care of patients with MCI or dementia, this cohort study investigates associations between information provided by amyloid PET scan and change in clinical management, defined as a composite of change in drug therapy or counseling about safety and future planning. </p>