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Completed

NCT Number: NCT03466736

Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]flutemetamol PET scan

Diagnostic Test

Each subject will receive an amyloid PET scan with [18F]flutemetamol

Primary outcomes

  1. short-term practice effects

    Time frame: baseline and one week

    Amount of improvement when cognitive tests are repeated twice within one week

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: APPE

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2018
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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