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Implications for Management of PET Amyloid Classification Technology (IMPACT)

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ClinicalTrials.gov Identifier: NCT02778971
Recruitment Status : Recruiting
First Posted : May 20, 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 explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction.

The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Dementia Alzheimer's Disease Drug: [18F]Flutemetamol

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Implications for Management of PET Amyloid Classification Technology
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Group/Cohort Intervention/treatment
Qualifying participants
All consented participants referred by a dementia expert physician to receive an amyloid PET scan with [18F]Flutametamol and meeting eligibility criteria will have visual and semi-quantitative software aided scan interpretation, complete care partner questionnaires and providers will document diagnosis, diagnostic confidence, and management plan before and after the scan.
Drug: [18F]Flutemetamol
amyloid PET imaging with [18F]Flutemetamol and subsequent modification of diagnosis and management
Other Name: Vizamyl




Primary Outcome Measures :
  1. Proportion of care practices changed 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. Proportion of drug management options changed 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. Proportion 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 a 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 and Visit 4, 90 days after scan ]
    Difference in a 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 a 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 a 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: at each visit, visits1-4, 120 days ]
    % 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. Proportion 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. Percentage of recommended care practices adhered to after amyloid PET scan [ Time Frame: Visit 4 90 days post scan ]
    % of care practices recommended after amyloid PET scan reported by care partner

  12. Percentage of recommended drug management adhered to after amyloid PET scan [ Time Frame: Visit 4 90 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

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants: Adults 45-90 years of age with a confirmed 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.
Criteria

Inclusion Criteria:

  • Patients must be 45 to 90 years of age for inclusion in this research study.
  • Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
  • Meets Appropriate Use Criteria (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.
  • MRI and/or CT of the brain within 12 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;
  • Patient must agree to have clinical and radiographic endpoints and the results of and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
  • Patient must be postmenopausal for a minimum of one year, surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test performed within 24 hours prior to research PET imaging.
  • All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.

Exclusion Criteria:

  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
  • Adult patients who require monitored anesthesia for PET scanning.
  • Patients who are too claustrophobic to undergo PET imaging.
  • Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.
  • Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
  • Subject's scans being ordered for one of the following reasons:

    • 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)
  • Currently pregnant
  • Patients who are unwilling to know the results of their PET imaging scan.

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): NCT02778971


Contacts
Contact: Rorie DuPrey, M.S., PMP 801-587-7888 rorie.duprey@hsc.utah.edu
Contact: Daniel Eike 801-585-0925 daniel.eike@hsc.utah.edu

Locations
United States, Utah
Center for Alzheimer's Care, Imaging & Research Recruiting
Salt Lake City, Utah, United States, 84108-1225
Contact: Daniel Eike    801-585-0925    daniel.eike@hsc.utah.edu   
Contact: Margaret Adams-Cooley, B.S.    801-587-7888    margaret.adams-cooley@hsc.utah.edu   
Principal Investigator: Norman L. Foster, M.D.         
Sub-Investigator: Richard D. King, M.D., Ph.D.         
Principal Investigator: John M. Hoffman, M.D.         
Sub-Investigator: Satoshi Minoshima, M.D., Ph.D.         
Sub-Investigator: Jeffery T. Yap, Ph.D.         
Sub-Investigator: Kevin Horn, M.D., Ph.D.         
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
Principal Investigator: John M. Hoffman, M.D. Professor of Radiology and Neurology Director of Nuclear Medicine; Director: Center for Quantitative Cancer Imaging Huntsman Cancer Institute 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: NCT02778971     History of Changes
Other Study ID Numbers: IMPACT-1
First Posted: May 20, 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

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

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