Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

NCT ID: NCT03466736

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-04-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cognitively intact older adults

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

[18F]flutemetamol PET scan

Intervention Type: DIAGNOSTIC_TEST

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

[18F]flutemetamol PET scan

Intervention Type: DIAGNOSTIC_TEST

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

[18F]flutemetamol PET scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

[18F]flutemetamol PET scan

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kevin Duff

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37224404 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37081822 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37038819 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35477163 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32883179 (View on PubMed)

Other Identifiers

R01AG055428

Identifier Type: NIH

Identifier Source: org_study_id

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