Clinical trial NCT03466736: Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
Official title: Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Keywords: practice effects
amyloid imaging
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-03-15
Enrollment: 165
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults who are either cognitively intact, have Mild Cognitive Impairment, or have Alzheimer's disease

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.


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

Primary outcomes:
measure: short-term practice effects
timeFrame: baseline and one week
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: 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.
citation: 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.