Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Alzheimer Disease Clinical Trial

— APPE  

Official title:

Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466736
• Other study ID #: R01AG055428
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: April 20, 2023

Study information

• Verified date: April 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Diagnostic Test:
• [18F]flutemetamol PET scan
Each subject will receive an amyloid PET scan with [18F]flutemetamol

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short-term practice effects	Amount of improvement when cognitive tests are repeated twice within one week	baseline and one week