ClinicalTrials.gov
ClinicalTrials.gov Menu

Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial (IMPACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02781220
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Norman Foster, University of Utah

Brief Summary:
The main purpose of this study is to build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.

Condition or disease
Mild Cognitive Impairment Dementia Alzheimer's Disease

Detailed Description:

The primary purpose of this prospective, observational study is to examine the benefit of amyloid positron emission tomography and computed tomography (PET/CT) scan in clinical practice for participants at our site that are enrolled in the IDEAS (NCT02420756) trial. To accomplish this, when a clinician has ordered an amyloid PET scan, the investigators will assess the impact of [18F]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.

The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.

Objectives

AIM 1: to assess the change in diagnosis and management, related to care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC)

AIM 2: to assess the change of amyloid PET/ CT scans on patient-reported outcomes involving care partner confidence and satisfaction

AIM 3: to assess confidence increase through use of vendor supplied semi-quantitative software

AIM 4: to assess adherence to identified patient management related to care practices and drug management


Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
Study Start Date : July 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019


Group/Cohort
Qualifying participants
All consented IDEAS trial participants will have additional data collected: visual and semi-quantitative software aided amyloid PET scan interpretation, care partner questionnaires and documented provider diagnosis, diagnostic confidence, and management plan following the IMPACT design



Primary Outcome Measures :
  1. Percentage of change in care practices after amyloid PET scan [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    % of 13 care practices that differ before and after the amyloid PET scan


Secondary Outcome Measures :
  1. Percentage of change in drug management options after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    % of drug management options that differ before and after the amyloid PET scan

  2. Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    Difference in % of AD likelihood identified before and after the amyloid PET scan

  3. Percentage of change in leading diagnosis after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    % of leading diagnosis that differ before and after amyloid PET scan

  4. Change in physician confidence in leading diagnosis [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    Difference in 5-point scale of physician confidence in leading diagnosis before and after amyloid PET scan

  5. Change in care partner's confidence in diagnosis after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan, Visit 4, 90 days after scan, Visit 5, 180 days after scan and Visit 6, 270 days after scan ]
    Difference in 5-point scale of care partner confidence in diagnosis before and after amyloid PET scan

  6. Change in care partner satisfaction with evaluation after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    Difference in 5-point scale of care partner satisfaction before team care and after amyloid PET scan

  7. Change in care partner assessment of the quality of evaluation after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
    Difference in 5-point scale of care partner quality before team care and after amyloid PET scan

  8. Proportion of care partners finding amyloid PET scan worthwhile [ Time Frame: Visit 4, 90 days after scan ]
    Proportion of care partners indicating they would agree to do an amyloid PET again on a yes/no/don't know scale

  9. Proportion exhibiting increased behavior disturbance during amyloid scan visit [ Time Frame: Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan ]
    % of patients showing a difference in the 44-point Catastrophic Reaction Scale between the median value in all non-scan visits and the value in the amyloid PET scan visit

  10. Percentage of change exhibiting increased behavior disturbance when the diagnosis is given [ Time Frame: Visit 1, Visit 3, 60 days ]
    % of patients showing a difference in the 44-point Catastrophic Reaction Scale between Visit 1 and Visit 3 when learning the result of the scan

  11. Care partner's sustained confidence in diagnosis received after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    Care partner confidence in diagnosis received after amyloid PET scan on a 5-point scale

  12. Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    Care partner confidence in ability to follow management plan outlined by physician after amyloid PET scan on a 5-point scale

  13. Percentage of recommended care practices adhered to after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    % of care practices recommended after amyloid PET scan reported by care partner

  14. Percentage of recommended drug management adhered to after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    % of drug management options recommended after amyloid PET scan reported by care partner


Other Outcome Measures:
  1. Change in the interpretation of amyloid PET scans with semi-quantitative image analysis [ Time Frame: within 30 days post amyloid PET scan ]
    Difference in a 5-point measure of amyloid scan positivity between a qualitative and semi-quantitative image analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 65 and older;
  • Medicare beneficiary;
  • Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (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 within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH); vitamin B12;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781220


Locations
United States, Utah
Center for Alzheimer's Care, Imaging & Research
Salt Lake City, Utah, United States, 84108-1225
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Norman L. Foster, M.D. Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine

Additional Information:
Publications:
Thal D, Beach TG, Zanette M, Heurling K, Buckley C, Smith A. [18F] Flutemetamol amyloid PET in Symptomatic Alzheimer's Disease (AD) and Pathologically Preclinical AD (P-Read) in Comparison to Non-AD Controls: Impact of Cerebral Amyloid Angiopathy. Alzheimer's & Dementia. 2014;10(4):P130.
Rowe CC, Dore V, Bourgeat P, et al. Higher AB Burden in Healthy APOE-E4 Carriers is Associated with Subjective Memory Complaints: Results from the Flutemetamol and PIB AIPL Cohorts. Alzheimer's & Dementia. 2014;10(4):P186-P187.
Adamczuk K, Schaeverbeke J, Nelissen N, et al. Comparison between semiquantitative measures and reader concordance of amyloid load based on 18F-flutemetamol versus 11C-PIB in cognitively intact older adults. Alzheimer's & Dementia. 2014;10(4):P143.
Heurling K, Miki T, Shimada H, et al. Blinded Visual Evaluation and Quantitative SUVR Threshold Classification of [18F]Flutemetamol PET Images in Japanese SUBJECTS. Alzheimer's & Dementia. 2014;10(4):P15.
Wolk DA, Duara R, Sadowsky C. [18F]Flutemetamol Amyloid PET Imaging: Outcome of a Phase III Study in Subjects with Amnestic Mild Cognitive Impairment after a 3-Year Follow-Up. Alzheimer's & Dementia. 2014;4(10):P898.
Hanseeuw B, Dricot L, Grandin C, Lhommel R, Quenon L, Ivanoiu A. Regional Brain Metabolism and Cortical Thickness in F18-Flutemetamol Amyloid-Positive Versus-Negative Mild Cognitve Impariment Patients. Alzheimer's & Dementia. 2014;10(4):P167-P168.
Schaeverbeke J, Adamczuk K, Bruffaerts R, et al. Comparison of 18F-Flutemetamol Uptake and CSF Measurements in Cognitively Intact Older Individuals. Alzheimer's & Dementia. 2014;4(10):P144.
AAPM Report No. 96: The Measurement, Reporting, and Management of Radiation Dose in CT. Report of AAPM Task Group 23 of the Diagnostic Imaging Council CT Committee. College Park, MD: American Association of Physicists in Medicine; 2008.

Responsible Party: Norman Foster, Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT02781220     History of Changes
Other Study ID Numbers: IMPACT-2
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: only de-identified data will be shared

Keywords provided by Norman Foster, University of Utah:
MCI
Dementia
amyloid PET
physician diagnosis
Alzheimer's disease
AD
PET imaging
Appropriate Use Criteria
patient-reported outcomes
patient adherence

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders