Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:12/13/2018
Start Date:September 1, 2018
End Date:April 30, 2022
Contact:Kevin Duff, PhD
Email:kevin.duff@hsc.utah.edu
Phone:8015859983

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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.


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
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-585-9983
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