Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Study Overview
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Brief Summary
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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.

Official Title
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Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Conditions
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Alzheimer Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: [18F]flutemetamol PET scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cognitively intact older adults<br>Each subject will receive an amyloid PET scan with [18F]flutemetamol | Diagnostic Test: [18F]flutemetamol PET scan<br>* Each subject will receive an amyloid PET scan with [18F]flutemetamol<br>|
| Mild Cognitive Impairment<br>Each subject will receive an amyloid PET scan with [18F]flutemetamol | Diagnostic Test: [18F]flutemetamol PET scan<br>* Each subject will receive an amyloid PET scan with [18F]flutemetamol<br>|
| Alzheimer's disease<br>Each subject will receive an amyloid PET scan with [18F]flutemetamol | Diagnostic Test: [18F]flutemetamol PET scan<br>* Each subject will receive an amyloid PET scan with [18F]flutemetamol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term practice effects | Amount of improvement when cognitive tests are repeated twice within one week | baseline and one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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practice effects, amyloid imaging