We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects (APPE)

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: NCT03466736
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : April 28, 2023
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin Duff, University of Utah

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to demonstrate that individuals with low short-term practice effects (STPE) on cognitive testing are more likely to be identified as "positive" on amyloid imaging than individuals with high STPE. STPE may also inform us about other AD-related biomarkers, including hippocampal volumes, functional connectivity, and APOE status. By realizing the aims of this pragmatic study, we hope to be able to offer more economical and efficient screening of potential participants for clinical trials, which would reduce participant burden and financial costs.

Condition or disease Intervention/treatment
Alzheimer Disease Mild Cognitive Impairment Diagnostic Test: [18F]flutemetamol PET scan

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : April 20, 2023
Actual Study Completion Date : April 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
cognitively intact older adults
Each subject will receive an amyloid PET scan with [18F]flutemetamol
 Diagnostic Test: [18F]flutemetamol PET scan
Each subject will receive an amyloid PET scan with [18F]flutemetamol
Mild Cognitive Impairment
Each subject will receive an amyloid PET scan with [18F]flutemetamol
 Diagnostic Test: [18F]flutemetamol PET scan
Each subject will receive an amyloid PET scan with [18F]flutemetamol
Alzheimer's disease
Each subject will receive an amyloid PET scan with [18F]flutemetamol
 Diagnostic Test: [18F]flutemetamol PET scan
Each subject will receive an amyloid PET scan with [18F]flutemetamol


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. short-term practice effects [ Time Frame: baseline and one week ]
    Amount of improvement when cognitive tests are repeated twice within one week


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Older adults who are either cognitively intact, have Mild Cognitive Impairment, or have Alzheimer's disease
Criteria

Inclusion Criteria:

  • 65 years or older
  • Identified as intact, Mild Cognitive Impairment, or Alzheimer's disease
  • Able to complete study procedures
  • All participants must have a collateral source (e.g. spouse, adult child, caregiver, close friend) available to briefly comment on the cognitive abilities and daily functioning of the participant. If the participant is diagnosed with probable AD dementia, a legally authorized representative (e.g. spouse, adult child) must be available to provide informed consent for the participant.

Exclusion Criteria:

  • History of major stroke, head injury with loss of consciousness of >30 minutes, or other neurological/systemic illness that may affect cognition
  • Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
  • History of substance abuse
  • Current use of antipsychotics or anticonvulsant medications
  • Known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
  • Need for monitored sedation or anesthesia during PET or MRI scanning.
  • Claustrophobia to a degree that the individual cannot undergo PET or MRI imaging
  • History of metal injury which precludes the individual from undergoing MRI imaging
  • Evidence of stroke or mass lesion on a CT or MRI scan
  • History of radiation therapy to the brain
  • History of significant major medical illnesses, such as cancer or AIDS.
  • Inadequate vision, hearing, and manual dexterity to participate in the cognitive assessments.
  • 15-item Geriatric Depression Scale score of >5
  • Clinical Dementia Rating score of >1
  • Mini Mental State Examination score of <20
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03466736


Locations
Layout table for location information
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Kevin Duff, Professor of Neurology, University of Utah
ClinicalTrials.gov Identifier: NCT03466736    
Other Study ID Numbers: R01AG055428 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Duff, University of Utah:
practice effects
amyloid imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action