Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Diagnostic Test: [18F]flutemetamol PET scan

• Registration Number: NCT03466736
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-15
• Study Start: 2018-09-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cognitively intact older adults	[18F]flutemetamol PET scan	Each subject will receive an amyloid PET scan with \[18F\]flutemetamol
Mild Cognitive Impairment	[18F]flutemetamol PET scan	Each subject will receive an amyloid PET scan with \[18F\]flutemetamol
Alzheimer's disease	[18F]flutemetamol PET scan	Each subject will receive an amyloid PET scan with \[18F\]flutemetamol

Primary Outcome Measures

Name	Time	Method
short-term practice effects	baseline and one week	Amount of improvement when cognitive tests are repeated twice within one week

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States