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Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03466736
Acronym
APPE
Enrollment
165
Registered
2018-03-15
Start date
2018-09-01
Completion date
2023-04-20
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment

Keywords

practice effects, amyloid imaging

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.

Interventions

DIAGNOSTIC_TEST[18F]flutemetamol PET scan

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
short-term practice effectsbaseline and one weekAmount of improvement when cognitive tests are repeated twice within one week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026