Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03121118
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2017-04-14
Brief Title:
Return of Amyloid Imaging Results RAISR Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Return of Amyloid Imaging Results
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISR
Brief Summary:
Diagnostic tests designed to detect Alzheimers disease AD pathology are increasingly popular in research on cognitive aging and AD Due to concerns that information from such tests may be misunderstood psychologically harmful and of unclear clinical significance results of pre mortem tests of AD pathology have typically been withheld from research participants However as the reliability and potential clinical significance of tests like brain amyloid imaging have become clear there is a pressing need to revisit the practice of unilaterally withholding such information from research participants and identify responsible approaches to communicating individual results Amyloid imaging results may be particularly relevant to mild cognitive impairment MCI a population for whom a growing body of evidence suggests that such testing may provide valuable prognostic and planning information despite the unavailability of interventions to alter ones clinical course Our preliminary work suggests that research participants with MCI and their family members are receptive to and capable of understanding information about the purpose results and implications of amyloid imaging when presented using a standardized approach developed by our interdisciplinary team Building on this work the proposed study will examine a well characterized sample of MCI care dyads patient family member who will be randomized to either receive the opportunity to decide if they would like to pursue an amyloid PET Scan or be randomized to not receive that opportunity and will serve in the no-scan comparison group This study aims to test hypotheses that examine how receiving amyloid imaging results will impact understanding of and perceived self-efficacy for coping with MCI among both patients and care partners
Detailed Description:
Objective
Advances in amyloid imaging are leading to unprecedented changes in research on cognitive aging We intend to characterize the way individuals respond to learning of the results of their amyloid imaging scans understand the context in which decisions to obtain results of brain amyloid status are made and examine the impact of such knowledge over the first year following results disclosure
Specific Aim
To determine the effect of receiving amyloid imaging results on understanding of and perceived efficacy to cope with Mild Cognitive Impairment MCI as a potential precursor to dementia
Hypothesis 1 MCI care dyads who receive amyloid imaging results using the text and visual aids developed by our interdisciplinary team will a perform better on objective assessments of basic knowledge about MCI and its relation to AD and b report lower levels of perceived ambiguity about what MCI means as compared to control MCI care dyads not receiving amyloid imaging
Hypothesis 2 MCI care dyads who receive the patients amyloid imaging results using the text and visual aids developed by our interdisciplinary team will report higher levels of perceived efficacy to cope with MCI as compared to those not participating in amyloid imaging
Background Amyloid imaging is a brain scanning technique that uses radioligands along with positron emission tomography PET to detect the presence of neuritic plaques associated with Alzheimers disease AD Evidence accumulating over the past decade suggests that current imaging techniques show fibrillar amyloid beta deposits in patients with known AD in a pattern consistent with post mortem pathological descriptions of amyloid plaque distribution 12 Although the prognostic utility of amyloid imaging in cognitively healthy older adults remains unclear it is increasingly evident that brain amyloid positivity may have significant implications for the long-term outcomes of individuals with mild cognitive impairment MCI
Across 5 published studies 155 persons with both amnestic and other subtypes of MCI have received amyloid PET scans and been followed longitudinally 3-7 Of these 155 individuals 101 were amyloid positive at baseline just over half n 53 of whom converted to dementia within 1 to 3 years By contrast only 74 n 4 of those who were amyloid negative at baseline converted to dementia within the same time period
This body of research suggests that regardless of MCI subtype amyloid imaging is a unique and powerful indicator of clinical outcomes in MCI This mounting evidence of the prognostic value of amyloid imaging underscores the significance of providing amyloid research participants who have MCI with information about and the choice of receiving their amyloid PET scan results It is recognized that such results are not medically actionable because there are no FDA-approved treatments for MCI or otherwise effective means of slowing progression to dementia
Despite the fact that amyloid PET research results are not medically actionable in MCI preliminary findings from our teams investigation of disclosing mock amyloid scan results to MCI care dyads patient family member indicate that these individuals are highly receptive to and generally capable of understanding information about amyloid-based biomarkers for AD including the limitations and limited clinical utility of such testing
Significance Amyloid imaging advances are leading to unprecedented changes in research on cognitive aging and AD As the field transitions into an era of pre-mortem testing for AD pathology amyloid imaging is playing a key role in identifying candidates for and evaluating effectiveness in anti-amyloid clinical trials Whereas tests of cognitive function have long been the gold standard for measuring treatment response amyloid-based markers are rapidly being adopted as secondary outcome measures and in some cases methodologies of choice for evaluating the effectiveness of experimental therapies targeting AD In clinical practice the recent FDA approval of the commercial amyloid imaging agent florbetapir suggests that in the near future tests of pre-mortem AD pathology while not sufficient to render a dementia diagnosis may augment clinical evaluations of cognitive impairment Findings from this research will lead to guidelines to assist clinicians in counseling and supporting individuals who are considering undergoing such testing
Advances in amyloid imaging are leading to unprecedented changes in research on cognitive aging We intend to characterize the way individuals respond to learning of the results of their amyloid imaging scans understand the context in which decisions to obtain results of brain amyloid status are made and examine the impact of such knowledge over the first year following results disclosure
Specific Aim
To determine the effect of receiving amyloid imaging results on understanding of and perceived efficacy to cope with Mild Cognitive Impairment MCI as a potential precursor to dementia
Hypothesis 1 MCI care dyads who receive amyloid imaging results using the text and visual aids developed by our interdisciplinary team will a perform better on objective assessments of basic knowledge about MCI and its relation to AD and b report lower levels of perceived ambiguity about what MCI means as compared to control MCI care dyads not receiving amyloid imaging
Hypothesis 2 MCI care dyads who receive the patients amyloid imaging results using the text and visual aids developed by our interdisciplinary team will report higher levels of perceived efficacy to cope with MCI as compared to those not participating in amyloid imaging
Background Amyloid imaging is a brain scanning technique that uses radioligands along with positron emission tomography PET to detect the presence of neuritic plaques associated with Alzheimers disease AD Evidence accumulating over the past decade suggests that current imaging techniques show fibrillar amyloid beta deposits in patients with known AD in a pattern consistent with post mortem pathological descriptions of amyloid plaque distribution 12 Although the prognostic utility of amyloid imaging in cognitively healthy older adults remains unclear it is increasingly evident that brain amyloid positivity may have significant implications for the long-term outcomes of individuals with mild cognitive impairment MCI
Across 5 published studies 155 persons with both amnestic and other subtypes of MCI have received amyloid PET scans and been followed longitudinally 3-7 Of these 155 individuals 101 were amyloid positive at baseline just over half n 53 of whom converted to dementia within 1 to 3 years By contrast only 74 n 4 of those who were amyloid negative at baseline converted to dementia within the same time period
This body of research suggests that regardless of MCI subtype amyloid imaging is a unique and powerful indicator of clinical outcomes in MCI This mounting evidence of the prognostic value of amyloid imaging underscores the significance of providing amyloid research participants who have MCI with information about and the choice of receiving their amyloid PET scan results It is recognized that such results are not medically actionable because there are no FDA-approved treatments for MCI or otherwise effective means of slowing progression to dementia
Despite the fact that amyloid PET research results are not medically actionable in MCI preliminary findings from our teams investigation of disclosing mock amyloid scan results to MCI care dyads patient family member indicate that these individuals are highly receptive to and generally capable of understanding information about amyloid-based biomarkers for AD including the limitations and limited clinical utility of such testing
Significance Amyloid imaging advances are leading to unprecedented changes in research on cognitive aging and AD As the field transitions into an era of pre-mortem testing for AD pathology amyloid imaging is playing a key role in identifying candidates for and evaluating effectiveness in anti-amyloid clinical trials Whereas tests of cognitive function have long been the gold standard for measuring treatment response amyloid-based markers are rapidly being adopted as secondary outcome measures and in some cases methodologies of choice for evaluating the effectiveness of experimental therapies targeting AD In clinical practice the recent FDA approval of the commercial amyloid imaging agent florbetapir suggests that in the near future tests of pre-mortem AD pathology while not sufficient to render a dementia diagnosis may augment clinical evaluations of cognitive impairment Findings from this research will lead to guidelines to assist clinicians in counseling and supporting individuals who are considering undergoing such testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None