Status:
COMPLETED
Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
65+ years
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 imagin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT03466736
Start Date
September 1 2018
End Date
April 20 2023
Last Update
April 28 2023
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108