Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects (APPE)

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Treatments

Diagnostic Test: [18F]flutemetamol PET scan

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03466736

R01AG055428

Details and patient eligibility

About

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.

Enrollment

165 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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