Implications for Management of PET Amyloid Classification Technology

NCT02778971 | Completed DMC

• 1 other identifier: 00084919
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Dementia; Alzheimer's Disease

Keywords

MCI; Dementia; amyloid PET; physician diagnosis; Alzheimer's disease; AD; PET imaging; Appropriate Use Criteria; patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• Proportion of care practices changed after amyloid PET scan

  % of 13 care practices that differ before and after the amyloid PET scan

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

Secondary Outcomes (12)

• Proportion of drug management options changed after amyloid PET

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

• Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

• Proportion of change in leading diagnosis after amyloid PET

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

• Change in physician confidence in leading diagnosis

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

• Change in care partner's confidence in diagnosis after amyloid PET

  Visit 1, 30 days prior to scan and Visit 4, 90 days after scan

Other Outcomes (1)

• Change in the interpretation of amyloid PET scans with semi-quantitative image analysis

  within 30 days post amyloid PET scan

Study Arms (1)

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

Interventions

[18F]Flutemetamol DRUG

amyloid PET imaging with \[18F\]Flutemetamol and subsequent modification of diagnosis and management

Also known as: Vizamyl

Qualifying participants

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Center for Alzheimer's Care, Imaging & Research

Salt Lake City, Utah, 84108-1225, United States

Location

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2022
• Last Updated: April 24, 2023

Record last verified: 2020-01

Locations

US (1)