Alzheimer DiseaseAPPENCT03466736
Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- [18F]flutemetamol PET scan
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults who are either cognitively intact, have Mild Cognitive Impairment, or have Alzheimer's disease
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- [18F]flutemetamol PET scan
- Keywords
- practice effects, amyloid imaging
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]flutemetamol PET scanDiagnostic test
Each subject will receive an amyloid PET scan with [18F]flutemetamol
| Study group | Role | What they receive |
|---|---|---|
| cognitively intact older adults | Each subject will receive an amyloid PET scan with [18F]flutemetamol Receives: Diagnostic Test: [18F]flutemetamol PET scan | |
| Mild Cognitive Impairment | Each subject will receive an amyloid PET scan with [18F]flutemetamol Receives: Diagnostic Test: [18F]flutemetamol PET scan | |
| Alzheimer's disease | Each subject will receive an amyloid PET scan with [18F]flutemetamol Receives: Diagnostic Test: [18F]flutemetamol PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term practice effects
Amount of improvement when cognitive tests are repeated twice within one week
Measured: baseline and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Sep 2018
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kevin Duff, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466736
- Sponsor's protocol ID
- R01AG055428
- Acronym
- APPE
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2018
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reed AM, Duff K, Dibble LE, Paul SS, Hooyman A, Schaefer SY. Examining the Diagnostic Accuracy of a Novel Performance-Based Test for Alzheimer's Disease Screening. J Prev Alzheimers Dis. 2024;11(4):903-907. doi: 10.14283/jpad.2024.93.
PubMed 39044501Duff K, Hammers DB, Koppelmans V, King JB, Hoffman JM. Short-Term Practice Effects on Cognitive Tests Across the Late Life Cognitive Spectrum and How They Compare to Biomarkers of Alzheimer's Disease. J Alzheimers Dis. 2024;99(1):321-332. doi: 10.3233/JAD-231392.
PubMed 38669544Duff K, Dixon AM, Embree L, Hoffman JM. Change on the Repeatable Battery for the Assessment of Neuropsychological Status and its relationship to brain amyloid. J Clin Exp Neuropsychol. 2023 Mar;45(2):105-117. doi: 10.1080/13803395.2023.2216920. Epub 2023 May 24.
PubMed 37224404Duff K. Revisiting reliable change with Iverson (2001). Clin Neuropsychol. 2024 Feb;38(2):412-428. doi: 10.1080/13854046.2023.2202333. Epub 2023 Apr 20.
PubMed 37081822Duff K, Wan L, Embree L, Hoffman JM. Change in the Quick Dementia Rating System Across Time in Older Adults with and without Cognitive Impairment. J Alzheimers Dis. 2023;93(2):449-457. doi: 10.3233/JAD-221252.
PubMed 37038819Duff 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.
PubMed 35477163Duff 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.
PubMed 32883179
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects
- ClinicalTrials.gov ID
- NCT03466736
- Acronym / sponsor ID
- APPE / R01AG055428
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- practice effects, amyloid imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitively intact older adults | – | Diagnostic Test: [18F]flutemetamol PET scanEach subject will receive an amyloid PET scan with [18F]flutemetamol |
| Mild Cognitive Impairment | – | Diagnostic Test: [18F]flutemetamol PET scanEach subject will receive an amyloid PET scan with [18F]flutemetamol |
| Alzheimer's disease | – | Diagnostic Test: [18F]flutemetamol PET scanEach subject will receive an amyloid PET scan with [18F]flutemetamol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults who are either cognitively intact, have Mild Cognitive Impairment, or have Alzheimer's disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]flutemetamol PET scanEach subject will receive an amyloid PET scan with [18F]flutemetamol | Diagnostic test | Alzheimer's disease, Mild Cognitive Impairment, cognitively intact older adults |
Primary outcome
short-term practice effects
Time frame: baseline and one week
Amount of improvement when cognitive tests are repeated twice within one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 39044501Reed AM, Duff K, Dibble LE, Paul SS, Hooyman A, Schaefer SY. Examining the Diagnostic Accuracy of a Novel Performance-Based Test for Alzheimer's Disease Screening. J Prev Alzheimers Dis. 2024;11(4):903-907. doi: 10.14283/jpad.2024.93.
- Derived from this study: PubMed 38669544Duff K, Hammers DB, Koppelmans V, King JB, Hoffman JM. Short-Term Practice Effects on Cognitive Tests Across the Late Life Cognitive Spectrum and How They Compare to Biomarkers of Alzheimer's Disease. J Alzheimers Dis. 2024;99(1):321-332. doi: 10.3233/JAD-231392.
- Derived from this study: PubMed 37224404Duff K, Dixon AM, Embree L, Hoffman JM. Change on the Repeatable Battery for the Assessment of Neuropsychological Status and its relationship to brain amyloid. J Clin Exp Neuropsychol. 2023 Mar;45(2):105-117. doi: 10.1080/13803395.2023.2216920. Epub 2023 May 24.
- Derived from this study: PubMed 37081822Duff K. Revisiting reliable change with Iverson (2001). Clin Neuropsychol. 2024 Feb;38(2):412-428. doi: 10.1080/13854046.2023.2202333. Epub 2023 Apr 20.
- Derived from this study: PubMed 37038819Duff K, Wan L, Embree L, Hoffman JM. Change in the Quick Dementia Rating System Across Time in Older Adults with and without Cognitive Impairment. J Alzheimers Dis. 2023;93(2):449-457. doi: 10.3233/JAD-221252.
- Derived from this study: PubMed 35477163Duff 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.
- Derived from this study: PubMed 32883179Duff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term practice effects (time frame: baseline and one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466736, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.