NCT03466736: APPE

Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Completed Last updated 28 April 2023

What this trial tests

trial testing [18F]flutemetamol PET scan in Alzheimer Disease in 165 participants. Completed in 20 April 2023.

Timeline

1 September 2018

Primary endpoint
20 April 2023

20 April 2023

Quick facts

Lead sponsor	University of Utah
Status	Completed
Study type	OBSERVATIONAL
Enrollment	165
Start date	1 September 2018
Primary completion	20 April 2023
Estimated completion	20 April 2023
Sites	1 location across United States

Drugs / interventions tested

• [18F]flutemetamol PET scan

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

University of Utah

Who can join

65 and older, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association Between Motor Task Performance and Hippocampal Atrophy Across Cognitively Unimpaired, Amnestic Mild Cognitive Impairment, and Alzheimer's Disease Individuals.
   Schaefer SY, Malek-Ahmadi M, Hooyman A, King JB, et al · · 2022 · cited 13× · PMID 34958015 · DOI 10.3233/jad-210665
2. Repeatable battery for the assessment of neuropsychological status and its relationship to biomarkers of Alzheimer's disease.
   Duff K, Suhrie KR, Hammers DB, Dixon AM, et al · · 2023 · cited 12× · PMID 34713772 · DOI 10.1080/13854046.2021.1995050
3. The Quick Dementia Rating System and Its Relationship to Biomarkers of Alzheimer's Disease and Neuropsychological Performance.
   Duff K, Wan L, Levine DA, Giordani B, et al · · 2022 · cited 10× · PMID 35477163 · DOI 10.1159/000524548
4. A Closer Look at Practice Effects in Mild Cognitive Impairment and Alzheimer's Disease.
   Duff K, Dixon A, Embree L. · · 2024 · cited 8× · PMID 37323010 · DOI 10.1093/arclin/acad046
5. Short-Term Practice Effects on Cognitive Tests Across the Late Life Cognitive Spectrum and How They Compare to Biomarkers of Alzheimer's Disease.
   Duff K, Hammers DB, Koppelmans V, King JB, et al · · 2024 · cited 5× · PMID 38669544 · DOI 10.3233/jad-231392
6. Recognition subtests for the Repeatable Battery for the Assessment of Neuropsychological Status: Preliminary data in cognitively intact older adults, amnestic Mild Cognitive Impairment, and Alzheimer's disease.
   Duff K, Suhrie KR, Dalley BCA, Porter SM, et al · · 2021 · cited 5× · PMID 32883179 · DOI 10.1080/13854046.2020.1812724
7. Examining the Diagnostic Accuracy of a Novel Performance-Based Test for Alzheimer's Disease Screening.
   Reed AM, Duff K, Dibble LE, Paul SS, et al · · 2024 · cited 4× · PMID 39044501 · DOI 10.14283/jpad.2024.93
8. Change on the Repeatable Battery for the Assessment of Neuropsychological Status and its relationship to brain amyloid.
   Duff K, Dixon AM, Embree L, Hoffman JM. · · 2023 · cited 4× · PMID 37224404 · DOI 10.1080/13803395.2023.2216920