Return of Amyloid Imaging Results (RAISR Study)

NCT03121118 | Completed DMC

• 1 other identifier: PRO13100338
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diagnostic tests designed to detect Alzheimer's 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 one's 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Amyvid; Amyloid Imaging; PET Brain Scan; Amyloid Plaque; Ethics; Results disclosure

Outcome Measures

Primary Outcomes (3)

• Understanding of mild cognitive impairment as a potential precursor to dementia--knowledge

  Score on a knowledge questionnaire

  One month followup

• Understanding of mild cognitive impairment as a potential precursor to dementia-Coherence

  Score on Brief Illness Perception Questionnaire Coherence Subscale

  One month followup

• Perceived efficacy to cope with mild cognitive impairment as a potential precursor to dementia

  Score on Coping Self-Efficacy Scale

  One month followup

Study Arms (2)

Scan opportunity

40 dyads comprised of individuals with Mild Cognitive Impairment and a study partner who is either a family member or kin-like friend.

Other: Scan Opportunity

Comparison group

40 dyads comprised of individuals with Mild Cognitive Impairment and a study partner who is either a family member or kin-like friend.

Interventions

Scan Opportunity OTHER

Participants in the scan group are provided the option of having an amyloid PET brain scan and receiving their results which can inform them of risk for developing Alzheimer's Disease.

Scan opportunity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 mild cognitive impairment dyads (patient + family member or kin-like friend). Mild cognitive impairment can consist of isolated impairment in memory; isolated deficit in non-memory domain; or, mild deficits in multiple cognitive domains.

You may qualify if:

• All MCI participants:
• Participant at the Pittsburgh Alzheimer's Disease Research Center, or other cognitive impairment studies.
• Carry a current diagnosis of MCI
• Have a family member or kin-like friend who also signs informed consent to participate
• Female participants must be 5 years post menopausal by self-report
• All family member participants:
• \) At least 18 years of age 2) Can read and write English

You may not qualify if:

• All MCI patient participants:
• familial AD genetic mutation carriers (this group already has biomarker-derived knowledge of their dementia risk)
• evidence of active, untreated primary psychiatric disorders defined as a CES-D (Depression Rating Scale) score of \>=16 or a Spielberger State Anxiety score of \>40 (to minimize the possibility of adverse events and to reduce any confounding influence of baseline mood)
• Active suicidal ideation indicated via the Beck Scale for Suicidal Ideation and verified by clinician interview.
• Participants with MCI and their primary participating family member:
• \) Inability to provide direct consent to the study based on performance on the University of San Diego Brief Assessment of Capacity to Consent (meaning, proxy consent will not be accepted).

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (5)

• Kim H, Lingler JH. Disclosure of amyloid PET scan results: A systematic review. Prog Mol Biol Transl Sci. 2019;165:401-414. doi: 10.1016/bs.pmbts.2019.05.002. Epub 2019 Jun 13.

  PMID: 31481171 BACKGROUND

• Lingler JH, Butters MA, Gentry AL, Hu L, Hunsaker AE, Klunk WE, Mattos MK, Parker LS, Roberts JS, Schulz R. Development of a Standardized Approach to Disclosing Amyloid Imaging Research Results in Mild Cognitive Impairment. J Alzheimers Dis. 2016 Mar 8;52(1):17-24. doi: 10.3233/JAD-150985.

  PMID: 27060950 BACKGROUND

• Lingler JH, Sereika SM, Butters MA, Cohen AD, Klunk WE, Knox ML, McDade E, Nadkarni NK, Roberts JS, Tamres LK, Lopez OL. A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment. Alzheimers Dement. 2020 Sep;16(9):1330-1337. doi: 10.1002/alz.12129. Epub 2020 Jun 26.

  PMID: 32588971 RESULT

• Mattos MK, Sereika SM, Beach SR, Kim H, Klunk WE, Knox M, Nadkarni NK, Parker LS, Roberts JS, Schulz R, Tamres L, Lingler JH. Research Use of Ecological Momentary Assessment for Adverse Event Monitoring Following Amyloid-beta Results Disclosure. J Alzheimers Dis. 2019;71(4):1071-1079. doi: 10.3233/JAD-190091.

  PMID: 31322563 RESULT

• Lingler JH, Roberts JS, Kim H, Morris JL, Hu L, Mattos M, McDade E, Lopez OL. Amyloid positron emission tomography candidates may focus more on benefits than risks of results disclosure. Alzheimers Dement (Amst). 2018 May 30;10:413-420. doi: 10.1016/j.dadm.2018.05.003. eCollection 2018.

  PMID: 30094328 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer H Lingler, RN, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: September 17, 2014
• Primary Completion: September 30, 2019
• Study Completion: May 31, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share