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

April 26, 2023 updated by: Kevin Duff, University of Utah
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short-term practice effects
Time Frame: baseline and one week
Amount of improvement when cognitive tests are repeated twice within one week
baseline and one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG055428 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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