Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

NCT03466736 | Completed DMC FDA Drug

• 1 other identifier: R01AG055428
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

practice effects; amyloid imaging

Outcome Measures

Primary Outcomes (1)

• short-term practice effects

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

  baseline and one week

Study Arms (3)

cognitively intact older adults

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

Diagnostic Test: [18F]flutemetamol PET scan

Mild Cognitive Impairment

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

Diagnostic Test: [18F]flutemetamol PET scan

Alzheimer's disease

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

Diagnostic Test: [18F]flutemetamol PET scan

Interventions

[18F]flutemetamol PET scan DIAGNOSTIC_TEST

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

Alzheimer's disease; Mild Cognitive Impairment; cognitively intact older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older adults who are either cognitively intact, have Mild Cognitive Impairment, or have Alzheimer's disease

You may qualify if:

• 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.

You may not qualify if:

• 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.
• item Geriatric Depression Scale score of \>5
• Clinical Dementia Rating score of \>1
• Mini Mental State Examination score of \<20

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (5)

• Duff K, Dixon AM, Embree L, Hoffman JM. Change on the Repeatable Battery for the Assessment of Neuropsychological Status and its relationship to brain amyloid. J Clin Exp Neuropsychol. 2023 Mar;45(2):105-117. doi: 10.1080/13803395.2023.2216920. Epub 2023 May 24.

  PMID: 37224404 DERIVED

• Duff K. Revisiting reliable change with Iverson (2001). Clin Neuropsychol. 2024 Feb;38(2):412-428. doi: 10.1080/13854046.2023.2202333. Epub 2023 Apr 20.

  PMID: 37081822 DERIVED

• Duff K, Wan L, Embree L, Hoffman JM. Change in the Quick Dementia Rating System Across Time in Older Adults with and without Cognitive Impairment. J Alzheimers Dis. 2023;93(2):449-457. doi: 10.3233/JAD-221252.

  PMID: 37038819 DERIVED

• Duff K, Wan L, Levine DA, Giordani B, Fowler NR, Fagerlin A, King JB, Hoffman JM. The Quick Dementia Rating System and Its Relationship to Biomarkers of Alzheimer's Disease and Neuropsychological Performance. Dement Geriatr Cogn Disord. 2022;51(3):214-220. doi: 10.1159/000524548. Epub 2022 Apr 27.

  PMID: 35477163 DERIVED

• Duff K, Suhrie KR, Dalley BCA, Porter SM, Dixon AM. 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. Clin Neuropsychol. 2021 Nov;35(8):1415-1425. doi: 10.1080/13854046.2020.1812724. Epub 2020 Sep 3.

  PMID: 32883179 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 15, 2018
• Study Start: September 1, 2018
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

US (1)