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Trial record 8 of 28 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Utah, United States ) | NIH, U.S. Fed

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03466736
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin Duff, University of Utah

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

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Study Type : Observational
Estimated Enrollment : 210 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
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

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




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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Kevin Duff, PhD 8015859983 kevin.duff@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Kevin Duff    801-585-9983    kevin.duff@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)

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Responsible Party: Kevin Duff, Professor of Neurology, University of Utah
ClinicalTrials.gov Identifier: NCT03466736     History of Changes
Other Study ID Numbers: R01AG055428 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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